Medical Device Testing

Worldwide certification of medical devices 

TÜV SÜD  Product Service is the largest Medical Device Notified Body, with accreditation for all medical devices and all conformity routes. With over 50 offices worldwide, we provide a professional and responsive medical device testing to assist clients in bringing their products to market in compliance with international, national and voluntary requirements.

Our range of services include medical device testing, quality system assessments, medical evaluation of clinical data and expert evaluation of technical files for compliance with CE marking regulations, such as certification to ISO 13485 / ISO 9001 and type testing.

We provide globally respected compliance services for International Regulations including the United States (third party reviewer for 510k applications and a third party inspector for the FDA), Japan (Registered Certification Body under the Japanese Pharmaceutical Affairs Law) and Canada (accredited by Health Canada to issue ISO 13485 certificates required as part of the Canadian Medical Device Conformity Assessment Scheme).

In addition to all the medical device related Directives, we are also a Notified / Competent Body for many other European Directives including the R&TTE , EMC and Low Voltage Directives .

TÜV SÜD Product Service provides a full range of testing, certification and training solutions and has considerable medical and health experience in:

TÜV SÜD Product Service is a member of

Click here to view more of our Medical capabilities with in the TÜV SÜD Group

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Call now to see how we can help you on +44 (0)1489 558100 or email us on info@tuvps.co.uk

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