DANSK DSF/ISO TR 24971 ED2 PDF

This document provides guidance on the development, implementation and maintenance of a risk management process for medical devices according to ISO 14971:20XX. The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016 [23], but this is not required by ISO 14971:20XX. Some requirements in ISO 13485:2016 [23] (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 14971:20XX. See also the ISO Handbook: ISO 13485:2016 – Medical devices – A practical guide [24].