Guideline for AI for medical products


🔘 Guide page:

Objective of the guideline

The objective of this guideline is to provide medical device manufacturers and notified bodies instructions and to provide them with a concrete checklist to understand what the expectations of the notified bodies are, to promote step-by-step implementation of safety of medical devices, that implement artificial intelligence methods, in particular machine learning, to compensate for the lack of a harmonized standard (in the interim) to the greatest extent possible.


undefined Prof. Dr. Christian Johner (Johner Institute).

undefinedChristoph Molnar (LMU Munich).

undefined Prof. Dr. Christian Dierks (Dierks + Company).

Dr. Andreas Purde, Dr. Abtin Rad (TÜV SÜD). Stefan Bunk (CTO) and Sven Piechottka (Government & Regulatory Affairs) (Merantix)

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