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"Demonstrating biological safety of medical devices and translating great ideas into commercial success" by Jean Marc De Vertueil, NAMSA

This presentation focuses on how medical device manufacturers should meet ISO 10993 requirements addressing biological risk and performance, in the context of EU and FDA regulatory submissions.

By looking at the history of medical device regulation we understand how regulatory agencies think today, and by sharing case studies of common mistakes and pitfalls, we learn how to develop a smooth path to regulatory approval.

This event will start at 8:30 with networking and coffee, followed by a prompt start with the presentations at 9:00.

Please register via our Eventbrite link: