ISO/TR 24971:2020
Medical devices — Guidance on the application of ISO 14971
OVERVIEW
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].
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2020 |
| No. of Pages | 87 |
| ICS Classification | 11.040.01 Medical equipment in general |
| Committee | ISO/TC 210 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |