CEN ISO/TR 24971:2020
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CEN ISO/TR 24971:2020
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
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This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 — Medical devices - A practical guide.
Collegati
The new ISO 13485:2016 standard is published
Dispositivi medici: la nuova edizione 2016 della norma EN ISO 13485
Expert Commentary on BS EN ISO 13485:2016
ISO 13485:2016 - Dispositivi medici - Guida pratica
UNI CEI EN ISO 14971:2020 | Dispositivi medici Gestione dei rischi
ISO 14971:2019 | Application of risk management to medical devices
ISO 14971:2019
EN ISO 14971 Dispositivi medici: Gestione e Valutazione del rischio
Dispositivi medici: la nuova edizione 2016 della norma EN ISO 13485
Expert Commentary on BS EN ISO 13485:2016
ISO 13485:2016 - Dispositivi medici - Guida pratica
UNI CEI EN ISO 14971:2020 | Dispositivi medici Gestione dei rischi
ISO 14971:2019 | Application of risk management to medical devices
ISO 14971:2019
EN ISO 14971 Dispositivi medici: Gestione e Valutazione del rischio
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CEN ISO TR 24971 2020 EN Preview.pdf CEN 2020 |
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Tags: Normazione Abbonati Normazione Regolamento Dispositivi Medici
