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Medical devices - Application of risk management to medical devices

Overview ISO 14971:2007 - Medical devices - Application of risk management to medical devices - defines a systematic process for identifying hazards, estimating and evaluating risks, implementing ris…

Medical devices - Guidance on the application of ISO 14971

Overview ISO/TR 24971:2020 - "Medical devices - Guidance on the application of ISO 14971" - is a technical report that provides practical guidance for developing, implementing and maintaining a medic…

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intellige…

Overview ISO/TS 24971-2:2026 provides important guidance for managing risks unique to artificial intelligence (AI) and machine learning (ML) in medical devices, referred to as ML-enabled medical devi…

Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intellige…

Overview CEN ISO/TS 24971-2:2026 provides essential guidance for applying the ISO 14971 risk management process specifically to medical devices that incorporate machine learning in artificial intelli…

Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intellige…

Overview SIST-TS CEN ISO/TS 24971-2:2026 is a technical specification developed by the Slovenian Institute for Standardization (SIST), in alignment with ISO and CEN, to provide guidance on applying t…

Medical devices -- Guidance on the application of ISO 14971

Overview ISO TR 24971:2013 - "Medical devices - Guidance on the application of ISO 14971" is a Technical Report that clarifies specific aspects of implementing ISO 14971 (medical device risk manageme…

Medical devices — Application of risk management to medical devices

Overview ISO 14971:2019 - Medical devices - Application of risk management to medical devices - defines a systematic process for identifying, evaluating, controlling and monitoring risks associated w…

Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software

Overview IEC/TR 80002-1:2009 - "Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software" is a technical report that provides targeted guidance for applyi…

Medical devices. Guidance on the application of ISO 14971 - Machine learning in artificial intelligence

What is PD CEN ISO/TS 24971-2 ED1 - Medical devices - Guidance on the application of ISO 14971 - Part 2: Machine learning in artificial intelligence about? PD CEN ISO/TS 24971-2 Edition 1 gives you g…

Medical device software - Guidance on the application of ISO 14971 to medical device software

PD IEC/TR 80002-1-1:2009 Medical device software. Guidance on the application of ISO 14971 to medical device software PD IEC/TR 80002-1-1 is a technical report aimed at risk management practitioners…

Medical devices. Application of risk management to medical devices

What is this standard about? Recognized by regulatory authorities in the US, Canada, Europe and more, this international standard helps medical device manufacturers establish, document and maintain a…

Medical devices. Application of risk management to medical devices

BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to…

Medical devices. Guidance on the application of ISO 14971

What is this published document about? Experience shows that manufacturers have difficulty with the practical implementation of some clauses in the medical devices risk management standard BS EN ISO…

Medical devices. Application of risk management to medical devices.