Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
Cyrille Michaud from MD101 Consulting is helping us to understand the new rule 11 to classify Software Devices in the European Union. This is a new rule so this creates a lot of discussion in the industry. Let's clarify that with Cyrille. The post Episode 19 – Rule 11 for Software Devices with Cyrille Michaud appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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Show Notes
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 Quality and Regulatory field with his customers. He will help us to have a better understanding of this rule and how manufacturers should work with it.
About Cyrille Michaud
Based in France, Cyrille Michaud is managing partner as MD101 Consulting. He is an information technology engineer with experience in both software and Quality Affairs/Regulatory Affairs. Prior to his current position, he was project director in a medical imaging start-up. His main achievements were the ISO 13485 certification and the CE Mark and FDA clearances. The value he brings: solving technical and regulatory issues, building business plans and regulatory strategies for manufacturers of software medical devices.
Links
- MD101 Consulting website: www.md101consulting.com
- MD101 Consulting Linkedin Page:
https://www.linkedin.com/company/md101-consulting/ - Cyrille Michaud Linkedin:
https://www.linkedin.com/in/cyrillemichaud/ - Blog Cyrille Michaud: http://blog.cm-dm.com/
- Rendez-Vous Expert Medtech: https://expertsmedtech.com/
- Episode 15 – MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/15
The post Episode 19 – Rule 11 for Software Devices with Cyrille Michaud appeared first on Medical Device made Easy Podcast. Monir El Azzouzi