Summary
Provides guidance on risks specific to artificial intelligence and machine learning and how to apply the ISO 14971 risk-management process to machine-learning-enabled medical devices. The technical specification is intended for use with ISO 14971 and ISO/TR 24971 and does not apply to ML-enabled medical devices using large language models or generative AI.
Healthcare Implications
Gives AI/ML medical-device developers, quality teams, and regulators an international reference for lifecycle risk management of ML-enabled medical devices. Health systems and purchasers can also use it as a vendor-evaluation reference for risk management, validation, monitoring, and documentation expectations, while recognizing that it does not cover LLM or generative-AI device functions.