Episode 19 – Rule 11 for Software Devices with Cyrille Michaud

Medical Device made Easy Podcast · Apr 15, 2019

Episode 19 – Rule 11 Software Devices with Cyrille Michaud MD101 Consulting Audio Episode 19 – Rule 11 Software Devices with Cyrille Michaud

With the evolution of software in the Medical Device industry, the legislation is also changing. With the MDD 93/42/EC software was not really a big topic, but today with Artificial Intelligence, Virtual Reality, Image recognition, Blockchain… it is important to consider it.

So the MDR 2017/745 created the classification rule 11 to provide some changes. Cyrille Michaud from MD101 Consulting is a software developer who works on the…