What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]

Medical Device made Easy Podcast · Aug 10, 2021

After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle.

Administrative work

Clinical evaluation

Biocompatibility

And Martin will also provide you some advice on how to be prepared for such an audit. He will also answer a bonus question which is: “Can we invite auditors to a restaurant or offer them a…