• Consulting

    ISO 22000 Certification

    Getting certified with the world's leading food safety management standard.

    ISO 13485 Certification

    Getting certified with the global standard used by healthcare industry.

    ISO 27001 Certification

    Getting certified with a globally accepted indication of security effectiveness.

    Medical Device Regulatory

    Establish a complete and effective medical device regulatory strategy.

    ISO Consulting

    Increase product and service quality with Stendard's ISO consulting.

  • Software

    Stendard Solution™

    Summary of our product and features that may help your business process even greater and possibly solve your difficulties in business process.

    Product Tour​

    Experience our EQMS software that is trusted by hundreds of companies.

    ISO Template

    Use our document generator to generate each Manual, Procedure, Form Templates and etc. Define the step-by-step instructions needed for each operation within the Work Instructions.

    Dashboard

    A powerful tool that streamlines the monitoring process and helps users make informed decisions based on the data that is most relevant to their needs.

    Library

    A simple but powerful module for you to store, organise and edit your files seamlessly without any hassle.

    Document Management System

    With Document Control, never worry about inaccuracy and non-compliance of documentation files and processes ever again.

    Workflow

    An effective way to reduce paperwork related hindrance within the workplace and improve organisational efficiency.

    Data Table

    With the ability to add, edit, and delete data, import data from external sources, and search and sort data, you can easily organize, analyze, and report on data in a more efficient manner.

    Form Builder

    Create any form that you need to support your daily activities. As the name suggests, building a form is now a breeze as you drag & drop components in.

    Academy

    Our aim at Stendard is not only to provide you with quality consulting services. We want to empower our clients such as yourself by providing a wide range of ISO related courses.

    Training Plan

    Create your training plan to group your training courses. By setting up these plan, you can set multiple items to be trained by several team members at once.

    Audit List

    Streamline your audit process by centralising all requirements in one place. Easily collect, review, and submit evidence to stay audit-ready.

    Evidence Submission

    Easily compile and organise all essential documents for regulatory submission. Confidently navigate upcoming submissions without worrying about missing files!

    Artificial Intelligence

    Our AI engine for Document Classification will help you significantly speed up the document classification process and allow less room for human error when handling these vast amounts of documents.

    Change Log

    Changelog will list all the updates and patches we have made to every software update to ensure that you know the new features or updates introduced to the system.

    Audit Trail

    You can ensure that accountability is incorporated into your organisation’s document management system with a robust audit trail system.

    Search (OCR)

    A simple but powerful tool to locate every single document you need.

  • Use Case

    How Industry Processes Are Managed Digitally

    Explore real examples of common industry processes and see how they can be managed digitally using Stendard Solution™.

    Nonconformity Management

    Track, investigate, and resolve nonconformities in a structured workflow. From submitting an NC report to completing root cause analysis and CAPA, every step is assigned, monitored, and documented in the system.

    CAPA Management

    Define, assign, and verify corrective and preventive actions with full visibility. CAPA activities are tracked from planning through effectiveness verification, all in one system.

    Risk Management

    Identify, assess, and control risks with full visibility across the organisation. Risks are managed from initial evaluation through mitigation actions and residual risk acceptance.

  • Academy
Stendard Solution™
Contact Us

Regulatory Strategy Consulting (Medical Device)

Your key to success is having a robust regulatory strategy aligned with your business strategy. As you identify the key markets you want to expand into, we can work closely with you to craft your regulatory approach and structure your business activities, to meet your targets.

Our Regulatory Services

Identifying the risk classification of your medical device and applicable regulatory requirements.

Advising on the best route for product registration, together with preparation of required documents for submission.

As product registration timelines vary based on countries and products, please contact us for more information about expected timelines for registration.

Product Registration License Holder

A good regulatory strategy should evolve according to changes in market needs and regulatory landscape.

Asean Countries

Across ASEAN, Stendard can help you achieve marketing authorisation of your devices – development of regulatory strategy (such as determining the risk classification of your device and the route to market), implementation of your QMS, preparation of the Technical Dossier, and submission of the application to regulatory authorities.

Singapore’s Health Sciences Authority (HSA)

Medical devices are regulated by Singapore’s Health Sciences Authority (HSA), via the Health Production Regulations (2010). They are categorised as either General Medical Devices or In-Vitro Medical Devices. You need to determine your device’s risk classification: Class A (lowest risk), Class B, Class C, Class D, or Class D with a registrable drug. If you’re not sure, you can use HSA’s risk classification tool but if you have any doubts, contact us!

To sell your devices in Singapore:

  • Class B, C and D devices require Product Registration, where you need to submit a Technical Dossier (i.e. ASEAN CSDT) to HSA via MEDICS for their review. Upon approval, the product will be listed on the SMDR.

If your device is already marketed in the USA, EU, Australia, Canada, or Japan, you may be eligible for faster product registration routes.

  • Class A are exempt from Product Registration but need to be listed via MEDICS.

If you are a foreign manufacturer of Cloud-based Class A software, we can also act as your Importer.

Also, to import, distribute, or manufacture medical devices in Singapore, you need the necessary Dealer’s license(s). Since compliance or certification to a Quality Management System (QMS) such as ISO 13485 is necessary to apply for a dealer’s license, Stendard can help implement your QMS and bring you through certification if necessary.

IMPORTANT

Registrant : If you’re not based in Singapore, you need a local company to register the device on your behalf.

Do you have a local presence in Singapore? If not, Stendard can act as your Registrant.

Dealer’s license : These are licenses that a local company requires to be a Importer, Distributor, or Manufacturer.

MEDICS : HSA’s online portal

SMDR: Singapore Medical Device Register

US, Europe, China and rest of the world

If you are looking to market your medical devices internationally, our QMS preparation services (ISO 13485 and US FDA 21 CFR) would have you prepared for the global market.

Additionally, we can serve as the main point of contact and anchor as you reach out internationally, as we work closely with our affiliated partners based in the US, Europe, China and other parts of the world.

With the most recent development of the Medical Device Regulation (MDR) in Europe, we are able to provide regulatory guidance to ensure smooth transition from the MDD.

The Global Influence of Stendard’s Services

Do you have any questions?

Drop us an inquiry now!

Get In Touch