ISO TR 24971:2020 

Medical devices - Guidance on the application of ISO 14971

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Abstract

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.

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Additional information

Publication typeTechnical Report
Publication date2020-06-16
Edition2.0
Available language(s)English
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
Stability date  2023
Pages87
File size3678 KB

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