Name:
ISO/TR 24971:2020 Plus Redline PDF
Published Date:
07/01/2020
Status:
Active
Publisher:
International Organization for Standardization (Technical Report)
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].
| File Size : | 1 file , 5 MB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 07/01/2020 |
