CSA ISO/TR 24971:21

Current Revision

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

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CSA ISO/TR 24971:21

Name: CSA ISO/TR 24971:21 – Medical devices — Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)
Brand: Canadian Standards Association
SKU: CSA ISO/TR 24971:21
Price: 290.00 USD
Availability: InStock

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

PUBLISH DATE 2021

CSA ISO/TR 24971:21

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].