The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) published a guidance document on 31 May on risk management for artificial intelligence and machine learning devices. The document has already been recognized as meeting the requirements for medical devices laid out in the US Food, Drug and Cosmetics Act.
The technical information report TIR 34971:2023, Application of ISO 14971 to machine learning in artificial intelligence – Guide is based on a 2022 consensus report (CR34971:2022) from AAMI....
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