Biological assessment of medical devices according to the ISO 10993-1 standard

The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation and demonstration of their biological assessment according to the ISO 10993-1 standard.

This guide, applicable to all medical devices (whatever their class and type), reviews the general principles, proposes a 7-step methodology corresponding to each section of GMED’s biological evaluation report. The guide also sets out the conditions for a biological evaluation file re-assessment.

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