In follow up to the plenary discussions in December 2022, ISO/TC 210 (AAMI QM, Quality management and corresponding general aspects for products with a health purpose including medical devices) Working Group has begun preparatory work on items for future revision of ISO 13485:2016.
The technical committee have launched a survey seeking feedback on the use of the standard for regulatory purposes. The intent of this survey is to gather stakeholder feedback on the existing use of the standard for regulatory purposes and to determine the benefits or negative impacts of a possible revision. The deadline to provide feedback is 31 December 2023.
More information on this survey can be found here.
