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BS PD CENISO/TR 24971:2020

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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