Abstract
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].
Buy together
ISO 13485:2016 + ISO 13485:2016 - Medical devices - A practical guide + ISO 14971:2019 + ISO/TR 24971:2019 ISO 13485:2016 ISO 13485:2016 59752 173 ISO 13485:2016 - Medical devices - A practical guide ISO 13485:2016 - Medical devices - A practical guide pub100484 96 ISO 14971:2019 ISO 14971:2019 72704 173 ISO/TR 24971:2020 ISO/TR 24971:2020 72704 216Medical devices - the basics
This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.
- ISO 13485:2016
- ISO 13485:2016 A practical guide
- ISO 14971:2019
- ISO/TR 24971:2020
General information
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Status: PublishedPublication date: 2020-06Stage: International Standard published [60.60]
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Edition: 2Number of pages: 87
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Technical Committee :ISO/TC 210ICS :11.040.01
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Life cycle
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Previously
WithdrawnISO/TR 24971:2013
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Now