ISO/AWI TS 24971-1

Projet

Un groupe de travail a préparé un projet.

Remplacera ISO/TR 24971:2020

Résumé

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, 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.

Informations générales

État actuel
: Projet

Stade
: Nouveau projet enregistré au programme de travail du TC/SC [20.00]
Edition
: 1
Comité technique :
ISO/TC 210
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