Medical & Health Services

Worldwide certification of medical devices

TÜV 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 service to assist clients in bringing their products to market in compliance with international, national and voluntary requirements.

Our range of services include product testing, quality system assessments, medical evaluation of clinical data and expert evaluation of technical files for compliance with CE marketing 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 Product Service provides a full range of testing, certification and training solutions and has considerable medical and health experience in:

ISO 13485 /  ISO 9001 Medical Device Services Environmental Testing

International Approvals EMC Testing

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

Benefits of using TÜV Product Service

We will help you bring your product to market as quickly as possible and the TÜV-Mark, issued to products that we test and certify, will give you considerable marketing advantage. You will receive free sales certificates and test reports within 5 days of completing the testing. You can benefit from the wealth of knowledge and experience that our consultants and engineers possess. We are happy to share our experience through our consultancy projects and bespoke training.

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Call now to see how we can help you on +44 (0)1489 558100