Medical devices— Guidance on the application of ISO 14971
|Publication Date:||1 January 2020|
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. See also the ISO Handbook: ISO 13485:2016 - Medical devices - A practical guide.
 ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes
 ISO Handbook: ISO 13485:2016, Medical devices - A practical guide