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Abstract Preview

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

  • Status :  Published
    Publication date : 2020-06
  • Edition : 2
    Number of pages : 87
  • Technical Committee
    :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • ICS :
    11.040.01
    Medical equipment in general

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