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This document defines terms in the field of quality management and corresponding general aspects for products with a health purpose including medical devices.
This document will provide the fundamental terminology used in quality management and the corresponding general aspects for products with a health purpose including medical devices. It will provide the foundation of understanding for other standards related to and required by a quality management system for regulatory purposes. This document is intended to help the user to understand the terminology of quality management systems and related subsystems required for medical device manufacturers and health care products, to be able to implement the related standards effectively. This document contains the terms and definitions that apply to all standards developed by ISO/TC 210 and other European standards in the same field of application.