Resumen
This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ϲʿ 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ϲʿ 13485:2016[24], but this is not required by ϲʿ 14971:2019. Some requirements in ϲʿ 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 ϲʿ 14971:2019. See also the ϲʿ Handbook: ϲʿ 13485:2016 — Medical devices — A practical guide[25].
In bundle
ϲʿ 13485:2016 + ϲʿ 13485:2016 - Medical devices - A practical guide + ϲʿ 14971:2019 + ϲʿ/TR 24971:2019 ϲʿ 13485:2016 ϲʿ 13485:2016 59752 173 ϲʿ 13485:2016 - Medical devices - A practical guide ϲʿ 13485:2016 - Medical devices - A practical guide pub100484 96 ϲʿ 14971:2019 ϲʿ 14971:2019 72704 173 ϲʿ/TR 24971:2020 ϲʿ/TR 24971:2020 72704 216Medical devices - the basics
This bundle combines essential ϲʿ standards to provide a robust framework for quality management and risk management in the medical device industry.
- ϲʿ 13485:2016
- ϲʿ 13485:2016 A practical guide
- ϲʿ 14971:2019
- ϲʿ/TR 24971:2020
Informaciones generales
Ciclo de vida
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Anteriormente
Retiradaϲʿ/TR 24971:2013
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Ahora
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