Improving the safety of medical devices
Reducing and managing risks related to medical devices is the objective of a key industry standard, ISO 14971. Detailed guidance to optimize its use has just been updated.
Abstract Preview
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].
General information
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Status : PublishedPublication date : 2020-06
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Edition : 2Number of pages : 87
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Technical Committee:Quality management and corresponding general aspects for medical devices
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- ICS :
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Medical equipment in general
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