Medical devices

Consulting

Compliance with the regulation of medical devices poses an increasingly difficult task for economic operators. In order to reduce the burden on economic operators, we provide full support for the CE marking of medical devices (MDR & IVDR), from regulatory strategy to post-market surveillance.

Standard, legislation, guidance

Description

Design and development of medical devices

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Product qualification support:

·        applicable legislation,

·        definition of relevant categories / classes.

MDR 10. (9) a)

Preparation of strategy for regulatory compliance:

·        key players in the target market,

·        conformity assessment procedure,

·        the contetnt of required documentation,

·        applicable standards and guidances.

MDR I.

Preparation of test plan:

identification of tests to verify the general safety and performance requirements of MDR Annex I.

EN 60601-1

EN 61010-2-101

Technical advice for the safe, standard design of devices.

 

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