AAMI CR34971 – Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for artificial intelligence (AI) or machine learning (ML) incorporating medical devices.

This AAMI Consensus Report does not provide a new risk management process, nor does it expand the requirements of ISO 14971. Rather, it provides guidance to assist those who are applying ISO 14971 to regulated AI medical technologies.

There are many different algorithms that can support AI, including technologies such as decision trees, genetic algorithms, and neural nets. Often, when people are discussing AI, they are specifically talking about Machine Learning systems. Since Machine Learning (ML) systems are often more complicated and more opaque than other approaches, this report focuses on ML-related risks.