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CEN ISO/TR 24971:2020
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
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Summary
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].
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].
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 07/25/2020 |
| Page Count | 6 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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CEN ISO/TR 24971:2020
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
25/07/2020
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