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ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

Data Bias in AI/ML-Enabled MedTech Takes Center Stage in Forthcoming ISO TS 24971-2 Risk Management Doc

By Shawn M. Schmitt Communications Specialist, Enzyme Data bias in medical devices that are enabled with artificial intelligence (AI) and machine learning (ML) will play a front-and-center role in an upcoming Technical Specification (TS) document from the International Organization for Standardization (ISO). ISO TS 24971-2 will serve as a companion guide to ISO TR 24971:2020,...