SIS-ISO/TR-24971 › Medical devices - Guidance on the application of ISO 14971
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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].
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11.040.01 (Medical equipment in general)
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Designation Name
SIS-ISO/TR 24971:2020
Revision Level
2020 EDITION
Status
Current
Publication Date
June 17, 2020
Language(s)
English
Page Count
96