? Guide page: github.com/johner-institut/ai-guideline
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.
Prof. Dr. Christian Johner (Johner Institute).
Christoph Molnar (LMU Munich).
Prof. Dr. Christian Dierks (Dierks + Company).