Medical Devices & Risk Analysis – ISO/TR 24971:2020

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ISO/TR 24971:2020 – 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 part of a quality management system, for example one that is based on ISO 13485:2016, 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.

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