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.
30 April 2018, 8:30 (Monday, 2nd week, Trinity 2018)
Botnar Research Centre, Headington OX3 7LD
Jean-Marc De Vertuil (NAMSA)
Nuffield Department of Surgical Sciences
Dr Regent Lee (University of Oxford )
Organiser contact email address:
Dr Toni Day (OrganOx),
Dr Regent Lee (University of Oxford ),
Dr Jeroen Bergmann (University of Oxford)
Members of the University only