How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)

Medical Device made Easy Podcast · Aug 24, 2021

Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings.

So I have invited Dr. Abtin Rad from TÜV SÜD to help us with this exercise. We will discuss with Abtin 3 main topics:

SaMD classification

Cybersecurity

Artificial Intelligence

And you’ll see that there are here a lot of tips for you to follow.

Who is Dr…