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This document provides guidance on the development, implementation and maintenance of a riskmanagement 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].
All current amendments available at time of purchase are included with the purchase of this document.
Product Details
- Published:
- 06/19/2020
- ISBN(s):
- 9780539066142
- Number of Pages:
- 96
- File Size:
- 1 file , 3.9 MB
- Same As:
- ISO/TR 24971:2020
- Product Code(s):
- 30403395, 30403395, 30403395