Oxford Events, the new replacement for OxTalks, will launch on 16th March. The two-week OxTalks freeze period starts on Monday 2nd March. During this time, there will be no facility to publish or edit events. The existing OxTalks site will remain available to view during this period. Once Oxford Events launches, you will need a Halo login to submit events. Full details are available on the Staff Gateway.
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.
