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AAMI TIR24971

Medical devices— Guidance on the application of ISO 14971

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Organization: AAMI
Publication Date: 1 January 2020
Status: active
Page Count: 99
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

AAMI TIR24971
January 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...
January 1, 2013
Medical devices - Guidance on the application of ISO 14971
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard...
January 1, 2013
Medical devices - Guidance on the application of ISO 14971
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard...

References

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