ISO/TS 24971-2:2026 – Risk Management for ML-Based Medical Devices
ISO/TS 24971-2:2026 specifies for the first time how manufacturers should apply ISO 14971 to machine learning components in AI-based medical devices and IVDs.Although this Technical Specification is not directly binding, it is likely to quickly become an important reference for manufacturers, Notified Bodies, and regulatory authorities.This article explains what the standard requires, how it is…
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