ISO TR 24971:2020
Medical devices - Guidance on the application of ISO 14971
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.
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.
Additional information
Publication type | Technical Report |
---|---|
Publication date | 2020-06-16 |
Edition | 2.0 |
Available language(s) | English |
TC/SC | TC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss |
ICS | 11.040.01 - Medical equipment in general |
Stability date | 2024 |
Pages | 87 |
File size | 3678 KB |
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