Our team of in-house consultants have experience in matters relating to Regulatory and Quality subjects, and are able to provide advisory services in these areas. For more information, please refer to our Consultancy Services page.

Our consultants’ expertise cover a wide range of ISO certifications, including ISO 13485, ISO 22000, ISO 27001, ISO 9001, besides Singapore standards such as SS 620 (GDPMDS) and SS 444.

These standards also take into account risk management related standards like the ISO 14971 as well as software-related standards like the IEC 62304.

Is it possible to have more than one ISO certification?
Yes, there is no problem with that!

Depending on your organisation’s processes, we are able to recommend the appropriate QMS scope and processes best suited for you. We have helped clients integrate various ISO certifications, such as the ISO 13485 and ISO 27001 in cases where they handle Software as a Medical Device and want to ensure information security.

To get certified, your organisation’s QMS must meet ISO requirements as outlined in the standard. We can help ensure that you meet these requirements!

Our in-house consultants have been technically trained to advise on the appropriate rigor of testings and checks to be performed as part of a robust QMS. This includes distributor/supplier/contract manufacturer audits, software validation, IQ/OQ/PQ tests, as well as clinical evaluation and sterility tests – all major components that make or break a QMS.

Furthermore, we can perform gap analyses and mock audits to support your team with identifying any issues and rectify any non-compliance, in preparation for your official ISO certification audits.

It is recommended for companies to include any activity covered to bring the product to the market. This covers Design & Development, Manufacturing, Distribution, and if applicable, servicing and sterilisation. As a Product Owner, one would include Manufacturing and Distribution activities, even if they have not started, or are to be outsourced. Listing only Design and Development would apply to companies that specialise in and only perform D&D.

Of course! Our team of consultants has plenty of experience with clients who needed to set up Quality Management Systems in line with the ISO 13485 and IEC 62304 standards, helping them meet both requirements for medical devices in general and those more software-specific.

We understand that in the world of software, development and production move at a fast and iterative pace. Given our experience working with many software companies, we can help you implement fully traceable processes for your team without being bogged down by paperwork, to fulfill standards and stay agile throughout the software lifecycle.

Our client base is located all over the world!

Besides applying the internationally-recognised ISO standards, we have specifically helped them expand to Europe, USA, Canada, South Korea, Australia, ASEAN regions. Our ISO consultants are able to provide guidance to fulfill what is required for successful manufacture, importation, and distribution of your products.

Yes, we have plenty of experience in supporting medical device product registrations in various markets throughout the world. Our consultants focused on regulatory compliance would be able to advise on the relevant submission process and documentation requirements.

Yes, we provide regulatory guidance and have helped our clients get their products CE-marked under the MDR, to enter the EU market!

This is a comprehensive service: covering advice on document content and technical reports to prepare and collate, post-market activities to set in place (eg. post-market clinical followup, product recall, etc.), European Authorised Representatives to appoint, Notified Bodies to engage for audit, besides actual submission to regulatory authorities.

Should you like to start making preparations on your own, we have a document generator that is primed to help you generate a customised set of QMS documents that fulfill MDR requirements. We can further assist you with reviews of records and documentation you prepare for submission to the regulatory authorities.

Please find the price list of the Stendard Solution™ here.

For a customised quotation for consultancy services required, please contact us and we will get in touch with you!