ISO-24971 › Medical devices - Guidance on the application of ISO 14971
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems
Standard Test Method for Seal Strength of Flexible Barrier Materials
Medical devices. Quality management systems. Requirements for regulatory purposes
June 1, 2020