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Posted on 24.04.2019

Regulatory affairs: One way of addressing the skill shortage Notified Bodies are facing

New EU Regulations on medical devices and in vitro diagnostic medical devices (IVDs) mean all stakeholders, including manufacturers, competent authorities, and Notified Bodies – need new knowledge and skills. The Regulations seek to harmonise requirements, capacities and competencies of Notified Bodies and to me, one of the key advances is the new responsibilities for Notified […]

By Prof. Dr. Folker Spitzenberger Professor at the University of Applied Sciences, Luebeck, Germany