This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.
AAMI TIR34971:2023
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Application of ISO 14971 to machine learning in artificial intelligence—Guide
Association for the Advancement of Medical Instrumentation , 03/14/2023
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