How to find your Predicate Device for your 510K Submission?

Medical Device made Easy Podcast · Nov 21, 2023

The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do.

Who is Beat Keller?

Beat is the Head of Regulatory Affairs and Quality Management at IMT, a Swiss Consultancy and Engineering Service…