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ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971
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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[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].

SDO ISO: International Organization for Standardization
Document Number ISO/TR 24971
Publication Date June 1, 2020
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 210
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