ISO/TR 24971:2020 Plus Redline

Medical devices - Guidance on the application of ISO 14971

standard by International Organization for Standardization (Technical Report) , 07/01/2020

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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^[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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Published:: 07/01/2020
File Size:: 1 file , 5 MB
Note:: This product is unavailable in Ukraine, Russia, Belarus