Global Market Access for Medical Devices

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Meet medical device compliance regulations and certification requirements with flexible, expert solutions from SGS.

Medical devices are essential tools for healthcare that have a direct impact on public health and quality of life. As a result, ensuring their safety is imperative.

When getting your product to market, you need to balance the demands of complex regulatory compliance and stringent quality requirements. SGS provides a range of services and solutions and a flexible, responsive approach to help you achieve a wide range of medical device compliance and certification.

Quality and Compliance Standards for Medical Device Manufacturers

ISO 13485:2016 – Quality Management Systems (QMS)

Confirm a validated QMS for medical device manufacturing and supply. Internationally recognized as the industry standard, an ISO 13485:2016 QMS can enable you to access the entire supply chain and help you bring your product to market.

UK Conformity Assessed (UKCA) Mark

The UKCA mark is the new UK medical device mark which can be used for medical devices being placed on the Great Britain (England, Wales, Scotland) market. It will not be recognized on the Northern Ireland market. As an approved body for the UKCA mark, SGS provides third-party assessment of conformity for medical device products.

European Medical Devices Regulation: MDR (EU) 2017/745

The CE Mark is a specific EU regulation legally required when bringing your medical device products to market. SGS provides CE Marking certification against MDR (EU) 2017/745, enabling you to use the CE Mark on your products.

Medical Device Single Audit Program (MDSAP)

SGS provides a single audit and certification for compliance with the standard and regulatory requirements of up to five different medical device markets, including Australia, Brazil, Canada, Japan and the United States.

FDA's Premarket Notification 510(k)

This is a pre-market application to the US FDA to validate that the device to be marketed is as safe, effective and substantially equivalent to a legally marketed device currently on the US market. SGS can help to shorten the process to get your 510(k) medical devices cleared through premarket notification.

Medical Device Training Courses

Our medical devices courses enable you to understand the most important sections of bringing a successful product to market within this highly regulated sector.

Why SGS?

SGS is the world’s leading inspection, verification, testing and certification company. Whatever your medical device or target market, we can help you ensure compliance to the appropriate mandatory quality and safety requirements.

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