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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