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Webinar: CE-Marking of Software medical device – new concepts around digital admission platforms and digital certification processes
11.07. von15:00 bis 16:00
First part: Introduction of the development of a digital submission platform to bridge the gap between manufacturers, Notified Bodies, authorities, and other actors.
Pierre Jäger strives for the vision of real-time certification of medical devices. He has been enabling actors related to medical and IVD devices for more than ten years to overcome regulatory hurdles in different roles including developer, quality manager, or responsible person and collaborated with many Notified Bodies to gain a broader perspective.
Second part: Software medical devices are fundamentally different from hardware medical devices. These differences have an impact on how they get CE-marked, and the process to get CE-marked has an impact on how these products are built. The webinar will outline these differences and how certification of software medical devices can be made more efficient.