ISO/TR 24971:2020
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ISO/TR 24971:2020
74437

Abstract

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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].


General information 

  •  :  Published
     : 2020-06
  •  : 2
     : 87
  •  : ISO/TC 210 Quality management and corresponding general aspects for medical devices
  •  :
    11.040.01 Medical equipment in general

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