PD CEN ISO/TR 24971:2020
Current
The latest, up-to-date edition.
Medical devices. Guidance on the application of ISO 14971
Hardcopy , PDF
English
22-07-2020
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/210/4
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| DocumentType |
Standard
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| Pages |
96
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO14971:2019.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 ISO14971:2019. Some requirements in ISO13485:2016 (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 ISO14971:2019. See also the ISO Handbook: ISO13485:2016 — Medical devices — A practical guide[ 25].
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