EU Regulatory Affairs and Liability Risks of AI-based Medical Devices

Manufacturers of medical devices based on artificial intelligence (AI) technologies are facing two major regulatory challenges in Europe: The fulfillment of the fundamental regulatory requirements for medical devices focusing on software and the Integration of special requirements for AI-based devices into the quality management system.

Dr. Thorsten Prinz, VDE
Leon Doorn, Aidence
Boris Handorn, Produktkanzlei

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