ISO/TR 24971:2020

Medical devices — Guidance on the application of ISO 14971

Publication date: Jun 16, 2020

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Current stage: 60.60 Effective date: Jun 16, 2020

Originator: ISO

Owner: ISO/TC 210

Type: Technical Report

ICS: 11.040.01

Languages: English French

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Status: Published

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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].

ISO/TR 24971:2020

Medical devices — Guidance on the application of ISO 14971

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