Demonstrating biological safety of medical devices and translating great ideas into commercial success

Please note the session will start with coffee/tea and networking at 8:30, followed by the presentation at 9:00

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.