Name:
DANSK DS/CEN ISO/TR 24971 PDF
Published Date:
07/27/2020
Status:
[ Active ]
Publisher:
Dansk Standard
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].
| Edition : | 20 |
| File Size : | 1 file , 3.7 MB |
| Number of Pages : | 100 |
| Product Code(s) : | DS-081, DS-081 |
| Published : | 07/27/2020 |
