Episode 19 – Rule 11 for 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 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
2 Replies to “Episode 19 – Rule 11 for Software Devices with Cyrille Michaud”
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Great presentation
Not sure that all imaging software are class III.
MRI software that compute signal to transform it in images for neuro or cardio diagnostic have different intended use than PACS that does not modify images but only archive them.
But the concern is not so simple considering compression algorithm and computing in Dicom format
Hi Vanhee,
Thanks for your comment.
I agree with you, most of MRI software for neuro or cardio will be in class IIa or IIb. The example I give in the video is just a very peculiar one, but still possible.