What is a Significant Change for your Medical Device? with Erik Vollebregt

Medical Device made Easy Podcast · Mar 30, 2020

This is a topic that all of you are talking about. What is a Significant Change to your Medical Device?

I may say, it depends and this is also the answer of Erik Vollebregt who is my guest in this episode of the Podcast.

He will help us understand what you should consider a Significant Change and also provide some examples like for Software companies or also for a change of suppliers or finally during a Merger and Acquisition.

Why is this is so important? Because this would have an impact on your transition period. If you have an MDD certificate that expires after May 26, 2020, then you can…