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CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

General information
Valid from 03.08.2020
Base Documents
ISO/TR 24971:2020; CEN ISO/TR 24971:2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
03.08.2020
Main
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[24], 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[25].
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