How to do Post-Marketing Surveillance in the US (vs EU)?

Medical Device made Easy Podcast · Jan 31, 2023

We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US you will see that this is really completely different.

For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you to gather data for your PMS. Let’s review that together.

Who is Robert Packard?

I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn…