{"id":263,"date":"2022-01-04T02:18:42","date_gmt":"2022-01-04T02:18:42","guid":{"rendered":"https:\/\/stendard.com\/index.php\/iso-certification-page-3\/"},"modified":"2023-07-17T15:49:13","modified_gmt":"2023-07-17T15:49:13","slug":"iso-13485-singapore","status":"publish","type":"page","link":"https:\/\/stendard.com\/en-sg\/iso-13485-singapore\/","title":{"rendered":"ISO Certification 13485 Page"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"263\" class=\"elementor elementor-263\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6ef2992b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6ef2992b\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;873d87d&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-7e4dbcd5\" data-id=\"7e4dbcd5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1573ebd4 elementor-widget elementor-widget-heading\" data-id=\"1573ebd4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">ISO 13485 Certification in Singapore<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-662057d5 elementor-widget elementor-widget-text-editor\" data-id=\"662057d5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>As you aim to achieve international recognition and access to the global medical device market, consumer trust is won through the assurance of having a proper ISO 13485-certified Quality Management System (QMS) in place.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-44056216\" data-id=\"44056216\" data-element_type=\"column\" 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= function(name, value) {\n    var now = new Date();\n    var time = now.getTime();\n    var expireTime = time + 1000 * 60 * 60 * 24 * 365;\n    now.setTime(expireTime);\n    document.cookie = name + '=' + value + '; expires=' + now + ';path=\/; Secure; SameSite=Lax;';\/\/ cannot be HttpOnly\n  }\n      var addEvent = function(element, event, func) {\n    if (element.addEventListener) {\n      element.addEventListener(event, func);\n    } else {\n      var oldFunc = element['on' + event];\n      element['on' + event] = function() {\n        oldFunc.apply(this, arguments);\n        func.apply(this, arguments);\n      };\n    }\n  }\n  var _removed = false;\n  var form_to_submit = document.getElementById('_form_1_');\n  var allInputs = form_to_submit.querySelectorAll('input, select, textarea'), tooltips = [], submitted = false;\n\n  var getUrlParam = function(name) {\n    var params = new URLSearchParams(window.location.search);\n    return params.get(name) || false;\n  };\n\n  for (var i = 0; i < allInputs.length; i++) {\n    var regexStr = \"field\\\\[(\\\\d+)\\\\]\";\n    var results = new RegExp(regexStr).exec(allInputs[i].name);\n    if (results != undefined) {\n      allInputs[i].dataset.name = window.cfields[results[1]];\n    } else {\n      allInputs[i].dataset.name = allInputs[i].name;\n    }\n    var fieldVal = getUrlParam(allInputs[i].dataset.name);\n\n    if (fieldVal) {\n      if (allInputs[i].dataset.autofill === \"false\") {\n        continue;\n      }\n      if (allInputs[i].type == \"radio\" || allInputs[i].type == \"checkbox\") {\n        if (allInputs[i].value == fieldVal) {\n          allInputs[i].checked = true;\n        }\n      } else {\n        allInputs[i].value = fieldVal;\n      }\n    }\n  }\n\n  var remove_tooltips = function() {\n    for (var i = 0; i < tooltips.length; i++) {\n      tooltips[i].tip.parentNode.removeChild(tooltips[i].tip);\n    }\n    tooltips = [];\n  };\n  var remove_tooltip = function(elem) {\n    for (var i = 0; i < tooltips.length; i++) {\n      if (tooltips[i].elem === elem) {\n        tooltips[i].tip.parentNode.removeChild(tooltips[i].tip);\n        tooltips.splice(i, 1);\n        return;\n      }\n    }\n  };\n  var create_tooltip = function(elem, text) {\n    var tooltip = document.createElement('div'), arrow = document.createElement('div'), inner = document.createElement('div'), new_tooltip = {};\n    if (elem.type != 'radio' && elem.type != 'checkbox') {\n      tooltip.className = '_error';\n      arrow.className = '_error-arrow';\n      inner.className = '_error-inner';\n      inner.innerHTML = text;\n      tooltip.appendChild(arrow);\n      tooltip.appendChild(inner);\n      elem.parentNode.appendChild(tooltip);\n    } else {\n      tooltip.className = '_error-inner _no_arrow';\n      tooltip.innerHTML = text;\n      elem.parentNode.insertBefore(tooltip, elem);\n      new_tooltip.no_arrow = true;\n    }\n    new_tooltip.tip = tooltip;\n    new_tooltip.elem = elem;\n    tooltips.push(new_tooltip);\n    return new_tooltip;\n  };\n  var resize_tooltip = function(tooltip) {\n    var rect = tooltip.elem.getBoundingClientRect();\n    var doc = document.documentElement, scrollPosition = rect.top - ((window.pageYOffset || doc.scrollTop)  - (doc.clientTop || 0));\n    if (scrollPosition < 40) {\n      tooltip.tip.className = tooltip.tip.className.replace(\/ ?(_above|_below) ?\/g, '') + ' _below';\n    } else {\n      tooltip.tip.className = tooltip.tip.className.replace(\/ ?(_above|_below) ?\/g, '') + ' _above';\n    }\n  };\n  var resize_tooltips = function() {\n    if (_removed) return;\n    for (var i = 0; i < tooltips.length; i++) {\n      if (!tooltips[i].no_arrow) resize_tooltip(tooltips[i]);\n    }\n  };\n  var validate_field = function(elem, remove) {\n    var tooltip = null, value = elem.value, no_error = true;\n    remove ? remove_tooltip(elem) : false;\n    if (elem.type != 'checkbox') elem.className = elem.className.replace(\/ ?_has_error ?\/g, '');\n    if (elem.getAttribute('required') !== null) {\n      if (elem.type == 'radio' || (elem.type == 'checkbox' && \/any\/.test(elem.className))) {\n        var elems = form_to_submit.elements[elem.name];\n        if (!(elems instanceof NodeList || elems instanceof HTMLCollection) || elems.length <= 1) {\n          no_error = elem.checked;\n        }\n        else {\n          no_error = false;\n          for (var i = 0; i < elems.length; i++) {\n            if (elems[i].checked) no_error = true;\n          }\n        }\n        if (!no_error) {\n          tooltip = create_tooltip(elem, \"Please select an option.\");\n        }\n      } else if (elem.type =='checkbox') {\n        var elems = form_to_submit.elements[elem.name], found = false, err = [];\n        no_error = true;\n        for (var i = 0; i < elems.length; i++) {\n          if (elems[i].getAttribute('required') === null) continue;\n          if (!found && elems[i] !== elem) return true;\n          found = true;\n          elems[i].className = elems[i].className.replace(\/ ?_has_error ?\/g, '');\n          if (!elems[i].checked) {\n            no_error = false;\n            elems[i].className = elems[i].className + ' _has_error';\n            err.push(\"Checking %s is required\".replace(\"%s\", elems[i].value));\n          }\n        }\n        if (!no_error) {\n          tooltip = create_tooltip(elem, err.join('<br\/>'));\n        }\n      } else if (elem.tagName == 'SELECT') {\n        var selected = true;\n        if (elem.multiple) {\n          selected = false;\n          for (var i = 0; i < elem.options.length; i++) {\n            if (elem.options[i].selected) {\n              selected = true;\n              break;\n            }\n          }\n        } else {\n          for (var i = 0; i < elem.options.length; i++) {\n            if (elem.options[i].selected && (!elem.options[i].value || (elem.options[i].value.match(\/\\n\/g)))) {\n              selected = false;\n            }\n          }\n   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address.\");\n      }\n    }\n    if (no_error && \/date_field\/.test(elem.className)) {\n      if (!value.match(\/^\\d\\d\\d\\d-\\d\\d-\\d\\d$\/)) {\n        elem.className = elem.className + ' _has_error';\n        no_error = false;\n        tooltip = create_tooltip(elem, \"Enter a valid date.\");\n      }\n    }\n    tooltip ? resize_tooltip(tooltip) : false;\n    return no_error;\n  };\n  var needs_validate = function(el) {\n        if(el.getAttribute('required') !== null){\n            return true\n        }\n        if(el.name === 'email' && el.value !== \"\"){\n            return true\n        }\n\n    if((el.id == 'field[]' || el.id == 'ca[11][v]') && el.className.includes('phone-input-error')){\n            return true\n        }\n\n        return false\n  };\n  var validate_form = function(e) {\n    var err = form_to_submit.querySelector('._form_error'), no_error = true;\n    if (!submitted) {\n      submitted = true;\n      for (var i = 0, len = allInputs.length; i < len; i++) {\n        var input = allInputs[i];\n        if (needs_validate(input)) {\n          if (input.type == 'tel') {\n            addEvent(input, 'blur', function() {\n              this.value = this.value.trim();\n              validate_field(this, true);\n            });\n          }\n          if (input.type == 'text' || input.type == 'number' || input.type == 'time') {\n            addEvent(input, 'blur', function() {\n              this.value = this.value.trim();\n              validate_field(this, true);\n            });\n            addEvent(input, 'input', function() {\n              validate_field(this, true);\n            });\n          } else if (input.type == 'radio' || input.type == 'checkbox') {\n            (function(el) {\n              var radios = form_to_submit.elements[el.name];\n              for (var i = 0; i < radios.length; i++) {\n                addEvent(radios[i], 'click', function() {\n                  validate_field(el, true);\n                });\n       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var errorMessage =  document.getElementById(\"error-msg-\" + inputId);\n    var input = document.getElementById(inputId);\n    errorMessage.classList.remove(\"phone-error\");\n    errorMessage.classList.add(\"phone-error-hidden\");\n    input.classList.remove(\"phone-input-error\");\n  };\n\n  var initializePhoneInput = function(input, defaultCountry) {\n    return window.intlTelInput(input, {\n      utilsScript: \"https:\/\/unpkg.com\/intl-tel-input@17.0.18\/build\/js\/utils.js\",\n      autoHideDialCode: false,\n      separateDialCode: true,\n      initialCountry: defaultCountry,\n      preferredCountries: []\n    });\n  }\n\n  var setPhoneInputEventListeners = function(inputId, input, iti) {\n    input.addEventListener('blur', function() {\n      var errorMessage = document.getElementById(\"error-msg-\" + inputId);\n      if (input.value.trim()) {\n        if (iti.isValidNumber()) {\n          iti.setNumber(iti.getNumber());\n          if (errorMessage.classList.contains(\"phone-error\")){\n            hidePhoneInputError(inputId);\n          }\n        } else {\n          showPhoneInputError(inputId)\n        }\n      } else {\n        if (errorMessage.classList.contains(\"phone-error\")){\n          hidePhoneInputError(inputId);\n        }\n      }\n    });\n\n    input.addEventListener(\"countrychange\", function() {\n      iti.setNumber('');\n    });\n\n    input.addEventListener(\"keydown\", function(e) {\n        var charCode = (e.which) ? e.which : e.keyCode;\n        if (charCode > 31 && (charCode < 48 || charCode > 57) && charCode !== 8) {\n               e.preventDefault();\n      }\n     });\n  };\n\n  var showPhoneInputError = function(inputId) {\n    var errorMessage =  document.getElementById(\"error-msg-\" + inputId);\n    var input = document.getElementById(inputId);\n    errorMessage.classList.add(\"phone-error\");\n    errorMessage.classList.remove(\"phone-error-hidden\");\n    input.classList.add(\"phone-input-error\");\n  };\n\n\n  window['recaptcha_callback'] = function() {\n  \/\/ Get all recaptchas in the DOM (there may be more than one form on the page).\n  var recaptchas = document.getElementsByClassName(\"g-recaptcha\");\n  for (var i in recaptchas) {\n    \/\/ Set the recaptcha element ID, so the recaptcha can be applied to each element.\n    var recaptcha_id = \"recaptcha_\" + i;\n    recaptchas[i].id = recaptcha_id;\n    var el = document.getElementById(recaptcha_id);\n    if (el != null) {\n      var sitekey = el.getAttribute(\"data-sitekey\");\n      var stoken = el.getAttribute(\"data-stoken\");\n      grecaptcha.render(recaptcha_id, {\"sitekey\":sitekey,\"stoken\":stoken});\n    }\n  }\n};  _load_script(\"https:\/\/www.google.com\/recaptcha\/api.js?onload=recaptcha_callback&render=explicit\");\n    var _form_serialize = function(form){if(!form||form.nodeName!==\"FORM\"){return }var i,j,q=[];for(i=0;i<form.elements.length;i++){if(form.elements[i].name===\"\"){continue}switch(form.elements[i].nodeName){case\"INPUT\":switch(form.elements[i].type){case\"tel\":q.push(form.elements[i].name+\"=\"+encodeURIComponent(form.elements[i].previousSibling.querySelector('div.iti__selected-dial-code').innerText)+encodeURIComponent(\" \")+encodeURIComponent(form.elements[i].value));break;case\"text\":case\"number\":case\"date\":case\"time\":case\"hidden\":case\"password\":case\"button\":case\"reset\":case\"submit\":q.push(form.elements[i].name+\"=\"+encodeURIComponent(form.elements[i].value));break;case\"checkbox\":case\"radio\":if(form.elements[i].checked){q.push(form.elements[i].name+\"=\"+encodeURIComponent(form.elements[i].value))}break;case\"file\":break}break;case\"TEXTAREA\":q.push(form.elements[i].name+\"=\"+encodeURIComponent(form.elements[i].value));break;case\"SELECT\":switch(form.elements[i].type){case\"select-one\":q.push(form.elements[i].name+\"=\"+encodeURIComponent(form.elements[i].value));break;case\"select-multiple\":for(j=0;j<form.elements[i].options.length;j++){if(form.elements[i].options[j].selected){q.push(form.elements[i].name+\"=\"+encodeURIComponent(form.elements[i].options[j].value))}}break}break;case\"BUTTON\":switch(form.elements[i].type){case\"reset\":case\"submit\":case\"button\":q.push(form.elements[i].name+\"=\"+encodeURIComponent(form.elements[i].value));break}break}}return q.join(\"&\")};\n  var form_submit = function(e) {\n    e.preventDefault();\n    if (validate_form()) {\n      \/\/ use this trick to get the submit button & disable it using plain javascript\n      document.querySelector('#_form_1_submit').disabled = true;\n            var serialized = _form_serialize(document.getElementById('_form_1_')).replace(\/%0A\/g, '\\\\n');\n      var err = form_to_submit.querySelector('._form_error');\n      err ? err.parentNode.removeChild(err) : false;\n      _load_script('https:\/\/stendard.activehosted.com\/proc.php?' + serialized + '&jsonp=true');\n    }\n    return false;\n  };\n  addEvent(form_to_submit, 'submit', form_submit);\n})();\n\n<\/script>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-41c191a3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"41c191a3\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;066deef&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3bf13b28\" data-id=\"3bf13b28\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6cdff3cc elementor-widget elementor-widget-heading\" data-id=\"6cdff3cc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Our Professional Services<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57428773 elementor-widget elementor-widget-text-editor\" data-id=\"57428773\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>I<b>SO 13485:2016 Medical Devices Quality Management Systems<\/b><\/p>\n<p>Our experienced team of in-house ISO consultants can plan and guide you through this process smoothly, covering critical areas for your company, as follows, to ensure you are well-established.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-28b6479 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"28b6479\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;066deef&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9f76679\" data-id=\"9f76679\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-58536fd elementor-widget elementor-widget-heading\" data-id=\"58536fd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Benefits of getting ISO 13485 certification\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c84f601 elementor-widget elementor-widget-text-editor\" data-id=\"c84f601\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h5><strong>ISO 13485 Medical Device Quality Management Systems<\/strong><\/h5><p>The most tangible benefit of having certification to the global standard &#8211;\u00a0<strong>ISO 13485 Medical Device Quality Management Systems<\/strong>&#8211; is market access. In most countries, the lack of this certification means that the company cannot operate in the medical devices industry. The products cannot be marketed for the same reason. That usually forms the most significant barrier to market entry.<\/p><p>If that is not already the most apparent benefit, companies with the ISO 13485 certification can also:<\/p><ul><li>Meet customer requirements and increase customer satisfaction through quality systems, meet product requirements and brand reputation;<\/li><li>Meet the requirements of applicable statutory and regulatory requirements;<\/li><li>Address product requirements, product quality and product safety without losing focus on business operations;<\/li><li>Improve clarity on management responsibility, decision-making processes;<\/li><li>Provide guidance towards proper resource management, including the people, infrastructure, processes involved, and overall work environment; and<\/li><li>Show commitment and focus towards patient safety.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-12fe146 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"12fe146\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;066deef&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8fe21a9\" data-id=\"8fe21a9\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fd69bcc elementor-widget elementor-widget-heading\" data-id=\"fd69bcc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 13485 certification cost in Singapore\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7881c61 elementor-widget elementor-widget-text-editor\" data-id=\"7881c61\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>ISO 13485 certification cost varies depending on your scope of works and your desired certification body to work with.\u00a0<a href=\"https:\/\/stendard.com\/en-sg\/contact\/\">Get in touch<\/a><span style=\"background-color: var( --e-global-color-secondary );\"> with us, and we can assist in getting a quotation from them!<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-be13c79 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"be13c79\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;066deef&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6d78e8c\" data-id=\"6d78e8c\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e1c4986 elementor-widget elementor-widget-heading\" data-id=\"e1c4986\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Stendard's ISO 13485 consultants in Singapore\n\n<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50061bb elementor-widget elementor-widget-text-editor\" data-id=\"50061bb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5ee2c71d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5ee2c71d\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;963f142&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}],&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-7dd77857\" data-id=\"7dd77857\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-66486680 elementor-widget elementor-widget-text-editor\" data-id=\"66486680\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>1.<\/strong><\/p><p>Identify the appropriate standard(s) that applies to your company, like the ISO 13485:2016 Quality Management System;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-108aea72\" data-id=\"108aea72\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-74a0fea3 elementor-widget elementor-widget-text-editor\" data-id=\"74a0fea3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>2.<\/b><\/p><p>Identify the scope of your ISO 13485 certification, set up appropriate processes and documentation;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-5da5b656\" data-id=\"5da5b656\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-16967b8a elementor-widget elementor-widget-text-editor\" data-id=\"16967b8a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>3.<\/b><\/p><p>Share knowledge on the ISO 13485 certification process;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-70b215c5\" data-id=\"70b215c5\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1674e315 elementor-widget elementor-widget-text-editor\" data-id=\"1674e315\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>4.<\/b><\/p><p>Ensure medical devices&#8217; design and development work is thorough;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3d5cabd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3d5cabd\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;4040d9a&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-223d57ee\" data-id=\"223d57ee\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-78473779 elementor-widget elementor-widget-text-editor\" data-id=\"78473779\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>5.<\/b><\/p><p>Ensure comprehensive coverage of medical devices&#8217; production and manufacturing activities;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-7d720eaf\" data-id=\"7d720eaf\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-46605c27 elementor-widget elementor-widget-text-editor\" data-id=\"46605c27\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>6.<\/b><\/p><p>Ensure that distribution channels for the medical devices, while extensive, are well-managed;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-42f721b8\" data-id=\"42f721b8\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ad1db74 elementor-widget elementor-widget-text-editor\" data-id=\"ad1db74\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>7.<\/b><\/p><p>Ensure the competency of your team regarding ISO 13485 standards and requirements through the conduct of training courses;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-44f44260\" data-id=\"44f44260\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6ec57553 elementor-widget elementor-widget-text-editor\" data-id=\"6ec57553\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>8.<\/b><\/p><p>Perform annual internal audit services with your team to ensure the effectiveness of your Quality Management System in preparation of ISO 13485 certification; and<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-393f6ae0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"393f6ae0\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;520a830&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-16d2c350\" data-id=\"16d2c350\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6d2c3f9d elementor-widget elementor-widget-text-editor\" data-id=\"6d2c3f9d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>9.<\/b><\/p><p>Recommending your team to third-party certification bodies providing ISO 13485 certification audit services.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-4e599586\" data-id=\"4e599586\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-478c2e6f\" data-id=\"478c2e6f\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-4612f05e\" data-id=\"4612f05e\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-40c4b0a0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"40c4b0a0\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;6a5d658&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6f3de061\" data-id=\"6f3de061\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-704bd0a0 elementor-widget elementor-widget-heading\" data-id=\"704bd0a0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Our consultants advise on which standard applies to your organisation<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c8e849a elementor-widget elementor-widget-text-editor\" data-id=\"6c8e849a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>ISO 13485:2016 Medical Devices Quality Management Systems<\/b><\/p><p>Of the many ISO standards to abide by, our consulting team would be able to best advise which applies to your company, to ensure appropriate compliance where necessary. You may find more than one ISO standard applicable to your medical devices and related services, and we can help you effectively integrate them to avoid unnecessary overlaps. For example, for Software as a Medical Device (SaMD) companies sometimes decide to adhere to both\u00a0<a href=\"https:\/\/stendard.com\/en-sg\/iso-13485\/\" target=\"_blank\" rel=\"noopener\">ISO 13485 (Medical Devices Quality Management System)<\/a>\u00a0and\u00a0<a href=\"https:\/\/stendard.com\/en-sg\/iso-27001\/\" target=\"_blank\" rel=\"noopener\">ISO 27001 (Information Security Management System)<\/a>.<\/p><p>Better understand the standards that the variety of our clients have engaged us for:<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-51c1cf51 elementor-mobile-align-justify elementor-widget elementor-widget-button\" data-id=\"51c1cf51\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/stendard.com\/en-sg\/iso-standards-list\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Show All Standards<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-19f79b59\" data-id=\"19f79b59\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-1b224e64 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"1b224e64\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;ad522b7&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-75f8aeba\" data-id=\"75f8aeba\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2f6b961a elementor-widget elementor-widget-text-editor\" data-id=\"2f6b961a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>ISO 13485:2016<\/p><p><b>Quality Management<br \/>Systems (Medical Devices)<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-12f4cdd4\" data-id=\"12f4cdd4\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d3aaca2 elementor-widget elementor-widget-text-editor\" data-id=\"d3aaca2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>ISO 22000:2018<\/p><p><b>Food Safety Management Systems<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-134252e\" data-id=\"134252e\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-24dc136a elementor-widget elementor-widget-text-editor\" data-id=\"24dc136a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>ISO 27001:2013<\/p><p><b>Information Security Management Systems<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4a4a0a58 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"4a4a0a58\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;2bb373a&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-7c360473\" data-id=\"7c360473\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6031947d elementor-widget elementor-widget-text-editor\" data-id=\"6031947d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>ISO 22301:2019<\/p><p><b>Business Continuity Management Systems<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-5f492fb4\" data-id=\"5f492fb4\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1ae0760e elementor-widget elementor-widget-text-editor\" data-id=\"1ae0760e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>SS 620:2016<\/p><p><b>Good Distribution Practices for Medical Devices(SG)<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-685e289a\" data-id=\"685e289a\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-39c6da75 elementor-widget elementor-widget-text-editor\" data-id=\"39c6da75\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>SS 444:2018<\/p><p><b>Hazards Analysis and Critical Control Points<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-33bb371f elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"33bb371f\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;85da820&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-fc25e54\" data-id=\"fc25e54\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-26695e29 elementor-widget elementor-widget-text-editor\" data-id=\"26695e29\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b style=\"background-color: var( --e-global-color-722c474c );\">EU Medical Devices Regulations (Upcoming)<\/b><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-75bee8b1\" data-id=\"75bee8b1\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-15b098a8\" data-id=\"15b098a8\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3a7fd5c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3a7fd5c\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;3857f3a&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4286fa07\" data-id=\"4286fa07\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5527209e elementor-widget elementor-widget-heading\" data-id=\"5527209e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">QMS Compliance<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a4d1ba8 elementor-widget elementor-widget-text-editor\" data-id=\"3a4d1ba8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>Our consultants scope your ISO 13485:2016 certification, setting up appropriate processes and documents for your Quality Management Systems<\/b><\/p>\n<p>Keeping in mind your current business practices, we work closely with your team to develop a robust Quality Management System (QMS) with minimal disruption to ongoing business activities, keeping in mind your customer requirements. Building on existing processes, we ensure compliance with your&nbsp;<a href=\"https:\/\/stendard.com\/en-sg\/iso-13485-singapore\/\" target=\"_blank\">ISO 13485 certification<\/a>&nbsp;requirements through the introduction of additional processes as needed.&nbsp;<\/p>\n<p><\/p>\n<p>Our structured approach to your QMS implementation provides a clear timeline for project milestones to be reached. Enjoy time saved through efficiency as we work closely over our Stendard Solution\u2122 platform, which allows for the smooth assignment of tasks and online collaboration, putting your management at ease by providing a birds\u2019-eye view at all times.<\/p>\n<p><\/p>\n<p>Through years of experience with ISO 13485 certification audits of a variety of medical devices companies owning hardware &amp; software products and services, our consultants will have you prepared for official audits conducted by your appointed ISO 13485 certification bodies.&nbsp;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-776bce4a\" data-id=\"776bce4a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-203edd5f elementor-widget elementor-widget-image\" data-id=\"203edd5f\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"768\" src=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-768x768.png\" class=\"attachment-medium_large size-medium_large wp-image-178\" alt=\"\" srcset=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-768x768.png 768w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-300x300.png 300w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-150x150.png 150w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1.png 948w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2977c5d6 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2977c5d6\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;0b92eab&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-66f699a8\" data-id=\"66f699a8\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5840af4a elementor-widget elementor-widget-heading\" data-id=\"5840af4a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Product Development (Design & Development)<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43c319c8 elementor-widget elementor-widget-text-editor\" data-id=\"43c319c8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>Our consultants review and confirm that your medical devices\u2019 design &amp; development work is completely in accordance to ISO 13485 requirements<\/b><\/p><p>We keep your medical devices\u2019 product registration and business strategies in mind as we put together your Design History Files (part of ISO 13485 requirements) so that your records are comprehensive enough to meet regulatory and customer requirements. This includes technical information as we help identify and highlight the depth of tests required (for example with clinical evaluation, sterility tests, software validation, etc.) for your medical devices.<\/p><p>With that, you can be ready for easy expansion to international markets! Our clients have entered major markets around the world: Singapore HSA, EU (under the new MDR), US FDA, Australia TGA, Canada MDEL, to name a few.\u00a0<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-373354a\" data-id=\"373354a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-632dde3c elementor-widget elementor-widget-image\" data-id=\"632dde3c\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"768\" height=\"768\" src=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-12-768x768.png\" class=\"attachment-medium_large size-medium_large wp-image-179\" alt=\"\" srcset=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-12-768x768.png 768w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-12-300x300.png 300w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-12-1024x1024.png 1024w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-12-150x150.png 150w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-12.png 1029w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4e46ebf5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4e46ebf5\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;4bb014f&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6a93eac5\" data-id=\"6a93eac5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6e724a95 elementor-widget elementor-widget-heading\" data-id=\"6e724a95\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Production, Manufacturing & Distribution<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3f1fef elementor-widget elementor-widget-text-editor\" data-id=\"b3f1fef\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>Our consultants ensures that you have comprehensive coverage for your medical devices from production &amp; manufacturing to distribution activities, with compliance to ISO 13485<\/b><\/p>\n<p>As we are increasingly well-connected globally, part of your organisation\u2019s medical devices may have been outsourced to various vendors or contract partners, while the core business activities were kept in-house.<\/p>\n<p>These activities may span the spectrum of the entire industry, from manufacturing and assembly to the distribution and installation of medical devices.&nbsp;<\/p>\n<p>Regardless, all processes need to be set up well, and our consultants can provide recommendations on how this may be done, in accordance with ISO 13485. From the evaluation of cleanrooms and factory layouts to quality checks to be performed, software validation to&nbsp;<a href=\"https:\/\/stendard.com\/en-sg\/blog\/iq-oq-pq\/\" target=\"_blank\">IQ, OQ, PQ<\/a>&nbsp;tests to be run, you can be assured that our broad experience provides thorough support for the set-up of production and manufacturing processes. We also advise on best practice distribution management to ensure traceability, in order to perform post-market surveillance activities when needed, such as that of customer requirements, feedback, product recalls, and post-market clinical follow-up.<\/p>\n<p>Post-setup of your Quality Management System, internal, supplier, and distributor audits would need to be performed on a regular basis (usually annually) to ensure compliance to regulations and standards. As required, we will walk the ground with you during these audits to ensure that all activities are compliant with your ISO 13485 certification and any other medical devices\u2019 regulations.&nbsp;<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-2efc83f2\" data-id=\"2efc83f2\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dedd98 elementor-widget elementor-widget-image\" data-id=\"dedd98\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"768\" height=\"714\" src=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Group-5633-1-768x714.png\" class=\"attachment-medium_large size-medium_large wp-image-182\" alt=\"\" srcset=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Group-5633-1-768x714.png 768w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Group-5633-1-300x279.png 300w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Group-5633-1-1024x952.png 1024w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Group-5633-1.png 1151w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7084b05 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7084b05\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;4bb014f&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-377af7f\" data-id=\"377af7f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a38b5bc elementor-widget elementor-widget-heading\" data-id=\"a38b5bc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Training and Competency\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26338d6 elementor-widget elementor-widget-text-editor\" data-id=\"26338d6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Our team ensures the competency of your team regarding ISO 13485 standards and requirements.<\/strong><\/p><p>We will include a combination of online training courses and in-person training to make sure everyone within your team understands the requirements of the medical devices&#8217; regulations and ISO 13485 standards and the application of your Quality Management System (QMS) processes and documents.<\/p><p>We take great pride in training your team. We believe that management and every team member must understand ISO 13485 and your products and services requirements, down to each clause within the standard. Due to the stringent nature of the industry, we would recommend each of our clients to start with our e-learning training courses before arranging for an in-depth session to explore all questions and unknowns.<\/p><p>Some of the e-learning course that we have created includes:<\/p><ul><li><strong>ISO 13485 Medical Devices QMS (Awareness course)<\/strong>\u00a0\u2014 Topics covered here include a clause-by-clause explanation for your team members to gain familiarity with the requirements; and<\/li><li><strong>Internal auditing for ISO 13485 Medical Devices QMS<\/strong>\u00a0\u2014 Topics include a full audit checklist where we share the methods to spot evidence and gap holes, according to the proprietary ISO 13485 requirements checklist.<\/li><\/ul><p>After that, we will conduct a face-to-face or online discussion session customised to your organisation&#8217;s needs for clarifications to be addressed, and an opportunity to brief the management on the readiness towards an audit conducted right after.<\/p><p><a href=\"https:\/\/stendard.com\/en-sg\/iso-course-singapore\/\" target=\"_blank\" rel=\"noopener noreferrer\">VIEW OUR E-LEARNING COURSES<\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-36246f6\" data-id=\"36246f6\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-801621d elementor-widget elementor-widget-image\" data-id=\"801621d\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"768\" src=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Audit-Preparation-1-768x768.png\" class=\"attachment-medium_large size-medium_large wp-image-1016\" alt=\"\" srcset=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Audit-Preparation-1-768x768.png 768w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Audit-Preparation-1-300x300.png 300w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Audit-Preparation-1-150x150.png 150w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Audit-Preparation-1.png 885w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c386304 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c386304\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;4bb014f&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-59560bf\" data-id=\"59560bf\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3b834f4 elementor-widget elementor-widget-heading\" data-id=\"3b834f4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Audit Preparation\n<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21d1f08 elementor-widget elementor-widget-text-editor\" data-id=\"21d1f08\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Our consultants can assist in annual internal\/mock audits.<\/strong><\/p><p>We understand the pressure to prepare for ISO 13485 audits conducted by external auditors.<\/p><p>Our consultants, experienced with seeing clients through the ISO 13485 certification process, can perform internal audits to support your team. This is done by identifying any issues and rectifying any non-compliance in preparation for your ISO 13485 certification audits.<\/p><p>Conducting internal audits ensures that your ISO 13485 Quality Management System&#8217;s effectiveness.<\/p><p>These may be in the form of pre-certification gap analysis or mock audits. These activities help us highlight gaps in your medical device quality management system that may need to be addressed.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-be39894\" data-id=\"be39894\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f738c09 elementor-widget elementor-widget-image\" data-id=\"f738c09\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"768\" src=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-768x768.png\" class=\"attachment-medium_large size-medium_large wp-image-178\" alt=\"\" srcset=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-768x768.png 768w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-300x300.png 300w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1-150x150.png 150w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-22-1.png 948w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6deb84ee elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6deb84ee\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;8e5efa5&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5c49d4fc\" data-id=\"5c49d4fc\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-74cb6ae2 elementor-widget elementor-widget-heading\" data-id=\"74cb6ae2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Training and Competency<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-71999371 elementor-widget elementor-widget-text-editor\" data-id=\"71999371\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><b>Our team ensures the competency of your team regarding ISO 13485 standards and requirements<\/b><\/p>\n<p>We include a combination of online training courses and in-person training to make sure everyone within your team understands the requirements of the medical devices\u2019 regulations and ISO 13485 standards, as well as the application of your QMS processes and documents.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f1f8522 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"f1f8522\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;19162cd&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-f2a34cf\" data-id=\"f2a34cf\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b08dc5 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"2b08dc5\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-widget-image-box .elementor-image-box-content{width:100%}@media (min-width:768px){.elementor-widget-image-box.elementor-position-left .elementor-image-box-wrapper,.elementor-widget-image-box.elementor-position-right .elementor-image-box-wrapper{display:flex}.elementor-widget-image-box.elementor-position-right .elementor-image-box-wrapper{text-align:right;flex-direction:row-reverse}.elementor-widget-image-box.elementor-position-left .elementor-image-box-wrapper{text-align:left;flex-direction:row}.elementor-widget-image-box.elementor-position-top .elementor-image-box-img{margin:auto}.elementor-widget-image-box.elementor-vertical-align-top .elementor-image-box-wrapper{align-items:flex-start}.elementor-widget-image-box.elementor-vertical-align-middle .elementor-image-box-wrapper{align-items:center}.elementor-widget-image-box.elementor-vertical-align-bottom .elementor-image-box-wrapper{align-items:flex-end}}@media (max-width:767px){.elementor-widget-image-box .elementor-image-box-img{margin-left:auto!important;margin-right:auto!important;margin-bottom:15px}}.elementor-widget-image-box .elementor-image-box-img{display:inline-block}.elementor-widget-image-box .elementor-image-box-title a{color:inherit}.elementor-widget-image-box .elementor-image-box-wrapper{text-align:center}.elementor-widget-image-box .elementor-image-box-description{margin:0}<\/style><div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><a href=\"https:\/\/solution.stendard.com\/public\/academy\/course\/3\/medical-devices-quality-management-system-iso-134852016\" tabindex=\"-1\"><img loading=\"lazy\" decoding=\"async\" width=\"2032\" height=\"1232\" src=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/13485-2016-Beginner.png\" class=\"attachment-full size-full wp-image-3041\" alt=\"\" srcset=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/13485-2016-Beginner.png 2032w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/13485-2016-Beginner-300x182.png 300w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/13485-2016-Beginner-1024x621.png 1024w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/13485-2016-Beginner-768x466.png 768w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/13485-2016-Beginner-1536x931.png 1536w\" sizes=\"(max-width: 2032px) 100vw, 2032px\" \/><\/a><\/figure><\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-06d0d1b elementor-widget elementor-widget-button\" data-id=\"06d0d1b\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/solution.stendard.com\/public\/academy\/course\/3\/medical-devices-quality-management-system-iso-134852016\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">See more info<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 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href=\"https:\/\/solution.stendard.com\/public\/academy\/course\/4\/internal-audit-on-medical-device-qms-iso-134852016\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">See more info<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d30ef91 elementor-widget elementor-widget-button\" data-id=\"3d30ef91\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/stendard.com\/en-sg\/iso-course-singapore\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-text\">View our e-learning courses<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a93db13 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a93db13\" data-element_type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;e39776e&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8ceb8e2\" data-id=\"8ceb8e2\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eed66f9 elementor-widget elementor-widget-heading\" data-id=\"eed66f9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Frequently Asked Questions<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b6f8fd elementor-widget elementor-widget-accordion\" data-id=\"8b6f8fd\" data-element_type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-accordion{text-align:left}.elementor-accordion .elementor-accordion-item{border:1px solid #d5d8dc}.elementor-accordion .elementor-accordion-item+.elementor-accordion-item{border-top:none}.elementor-accordion .elementor-tab-title{margin:0;padding:15px 20px;font-weight:700;line-height:1;cursor:pointer;outline:none}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{display:inline-block;width:1.5em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon svg{width:1em;height:1em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-right{float:right;text-align:right}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-left{float:left;text-align:left}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-closed{display:block}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-opened,.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-closed{display:none}.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-opened{display:block}.elementor-accordion .elementor-tab-content{display:none;padding:15px 20px;border-top:1px solid #d5d8dc}@media (max-width:767px){.elementor-accordion .elementor-tab-title{padding:12px 15px}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{width:1.2em}.elementor-accordion .elementor-tab-content{padding:7px 15px}}.e-con-inner>.elementor-widget-accordion,.e-con>.elementor-widget-accordion{width:var(--container-widget-width);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1461\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1461\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How do I get ISO 13485 certified?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1461\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1461\"><p>Stendard can help your organisation by providing ISO 13485 Medical Device Quality Management Systems consulting services with experienced ISO 13485 consultants. We help individual clients prepare, establish, implement and improve their medical device management system processes, including <a href=\"https:\/\/stendard.com\/en-sg\/blog\/gap-analysis\/\">gap analysis<\/a>, auditing, training and arranging for certification services from an internationally recognised certification body.<\/p><p>Alternatively, suppose your organisation already has a Quality Management System in place. In that case, you may start speaking to accredited certification bodies to conduct third-party audits to be certified.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1462\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1462\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Is ISO 13485 mandatory for medical devices?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1462\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1462\"><p><strong>ISO 13485 Medical Device Quality Management Systems\u00a0<\/strong>is not mandatory for medical devices. For regulatory purposes, it is highly recommended for all organisations involved in medical device manufacturing, design and development, and distribution activities.<\/p><p>ISO 13485 also depends highly on your medical devices&#8217; risk classification, according to various country&#8217;s regulatory requirements. For example in the United States of America, the Food and Drug Administration (FDA) specifies the need for compliance to the 21 CFR Part 820 Quality Systems instead of ISO 13485. It is highly recommended to have and ISO 13485 Quality Management System in place as it fulfils most of FDA&#8217;s 21 CFR Part 820 Quality Systems requirements.<\/p><p>Similarly, the<strong>\u00a0Regulations (EU) 2017\/745 &#8211; Medical Device Regulations (MDR)\u00a0<\/strong>have been established under the European Union. Depending on your medical device risk classification, a conformity assessment by a notified body on your medical devices quality management system may be required.<\/p><p>Although ISO 13485 is not mentioned under the MDR, the International Organization for Standardization has published the\u00a0<strong>EN ISO 13485:2016+A11:2021<\/strong>\u00a0standard which has comprehensive requirements matched to the\u00a0<strong>Regulations (EU) 2017\/745 &#8211; Medical Device Regulations\u00a0<\/strong>for organisations that aim to market their medical devices in the European Union.<\/p><p>Not sure if your organisation requires an ISO 13485 or EN ISO 13485:2016 certification? Feel free to <a href=\"https:\/\/stendard.com\/en-sg\/contact\/\">contact us<\/a>, and we would be happy to assist!<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1463\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1463\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is the difference between ISO 13485:2016 and EN ISO 13485:2016? <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1463\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1463\"><p>EN ISO 13485:2016 Specifies additional requirements in the Annexes to the European Union&#8217;s regulations, while ISO 13485:2016 does not. The main content clauses, however, do not differ.<\/p><p>Companies seeking to market their medical devices in Europe are recommended to comply with the new EN ISO 13485:2016+A11:2021 standard.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1464\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1464\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is the current version of the ISO 13485 standard?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1464\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1464\"><p>The current version of the ISO 13485 Medical Devices Quality Management Systems is ISO 13485:2016.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1465\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1465\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Does ISO 13485 replace ISO 9001?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1465\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1465\"><p>Partially. To add to the challenge, the most commonly adopted ISO standard \u2014 the ISO 9001 standard is also known as a Quality Management System. However, the ISO 9001 standard applies to many other industries, including construction, engineering, manufacturing, hotels &amp; hospitality, to name a few.<\/p><p>Being the number 1 most popular standard being certified to, anyone in this industry would be familiar with the ISO 9001 standard or have worked with an organisation with the ISO 9001 certification. This dramatically impacts the impression that the ISO 13485 standard is very similar, which is far from the truth due to the standard&#8217;s differences in structure and framework.<\/p><p>Looking deeper into their differences, the ISO 9001 requirements ensure that your organisation focuses on achieving customer satisfaction. At the same time, ISO 13485 puts a lot more emphasis on patient safety during the usage of medical devices and greater efficacy in the diagnosis results. In addition, ISO 9001 now requires product manufacturers to focus on continuous improvement. In contrast, ISO 13485 requires the company to demonstrate implementation and consistent maintenance of the quality management system.<\/p><p>Therefore, ISO 13485 does not replace ISO 9001. ISO 13485, however, can fulfil partial requirements of ISO 9001 and vice versa.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-74ae179 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"74ae179\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[{&quot;_id&quot;:&quot;857087c&quot;,&quot;jet_parallax_layout_image&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_tablet&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_image_mobile&quot;:{&quot;url&quot;:&quot;&quot;,&quot;id&quot;:&quot;&quot;,&quot;size&quot;:&quot;&quot;},&quot;jet_parallax_layout_speed&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:50,&quot;sizes&quot;:[]},&quot;jet_parallax_layout_type&quot;:&quot;scroll&quot;,&quot;jet_parallax_layout_direction&quot;:null,&quot;jet_parallax_layout_fx_direction&quot;:null,&quot;jet_parallax_layout_z_index&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x&quot;:50,&quot;jet_parallax_layout_bg_x_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_x_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y&quot;:50,&quot;jet_parallax_layout_bg_y_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_y_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size&quot;:&quot;auto&quot;,&quot;jet_parallax_layout_bg_size_tablet&quot;:&quot;&quot;,&quot;jet_parallax_layout_bg_size_mobile&quot;:&quot;&quot;,&quot;jet_parallax_layout_animation_prop&quot;:&quot;transform&quot;,&quot;jet_parallax_layout_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;]}]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-90d5e99\" data-id=\"90d5e99\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa7126d elementor-widget elementor-widget-image\" data-id=\"aa7126d\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"251\" height=\"251\" src=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-31.png\" class=\"attachment-large size-large wp-image-18\" alt=\"\" srcset=\"https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-31.png 251w, https:\/\/stendard.com\/wp-content\/uploads\/2022\/01\/Saly-31-150x150.png 150w\" sizes=\"(max-width: 251px) 100vw, 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