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ISO/TR 24971:2020

Medical devices -- Guidance on the application of ISO 14971

General information
Valid from 16.06.2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
16.06.2020
Main
19.06.2013
Main
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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