Medical devices. Guidance on the application of ISO 14971
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISOÂ 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].
| SDO | BSI: British Standards Institution |
| Document Number | ISO/TR 24971 |
| Publication Date | June 19, 2020 |
| Language | en - English |
| Page Count | 96 |
| Revision Level | |
| Supercedes | |
| Committee | CH/210/4 |