From 11 till 15 December 2023 ISO/TC 210 ‘Quality management and corresponding general aspects for products with a health purpose including medical devices’ will meet in Paris, France.
CEN TC 251 members Dr. Ilkka Juuso (Finland) and Jeanett Fleron (Denmark) will take part in the meetings as two of the shared voices between the two committees.
The meetings promise to be a full week of discussion on the status quo and the road ahead for many key medical-device standards. On the agenda, as always, will be ISO 13485 ‘Medical devices – Quality management systems – Requirements for regulatory purposes’ which today acts as the basis of a wealth of local and international regulatory efforts for medical devices across the globe.
Another big-ticket item this year will be post-market surveillance following the completion of a recent user survey. Also on the agenda will be many other important topics such as risk management, international collaboration, symbols, and terminology.
CEN/TC 251 takes an active role in international collaboration to ensure harmonized approaches to health informatics on all related domains. The interface between health informatics, health applications, and medical devices is a particularly important domain in this work.