62A/1516/NP Medical devices – Guidance on the application of ISO 14971 – Part 2: Machine learning in artificial intelligence

Comment period start date: 16/08/2023 Comment period end date: 03/10/2023 Scope This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in conjunction with ISO 14971. It…