CEN ISO/TR 24971:2020

Medical devices – Guidance on the application of ISO 14971 (ISO/TR 24971:2020)


Status:
Current
Type:
Standard
Language:
Subject:

Scope

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].

Number of pages: 0

International relationships :

Item number: M329420


Committees

Committee

  • CENCLC/JTC 3

Danish committee

DS/S-257