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ISO TR 24971 PLUS REDLINE

Medical devices — Guidance on the application of ISO 14971

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Organization: ISO
Publication Date: 1 June 2020
Status: active
Page Count: 198
ICS Code (Medical equipment in general): 11.040.01
scope:

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].

[24] ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes

[25] ISO Handbook: ISO 13485:2016, Medical devices - A practical guide

Document History

ISO TR 24971 PLUS REDLINE
June 1, 2020
Medical devices — Guidance on the application of ISO 14971
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...

References

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