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CSA ISO/TR 24971:21

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Medical devices — Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)

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Medical devices — Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)

Scope

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 CSA: Canadian Standards Association
Document Number
Publication Date Jan. 1, 2021
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
Jan. 1, 2021 CSA ISO/TR 24971:21 Revision
Jan. 1, 2021 CSA ISO/TR 24971:F21 Revision