CSA - ISO/TR 24971:21
Medical devices — Guidance on the application of ISO 14971
active, Most Current
| Organization: | CSA |
| Publication Date: | 1 January 2021 |
| Status: | active |
| Page Count: | 104 |
| ICS Code (Medical equipment in general): | 11.040.01 |
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].
Document History
ISO/TR 24971:21
January 1, 2021
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 ISO 14971:2019.
The risk management process can be...