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.