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This new Rule 11 for the classification of software from the EU MDR 2017/745 is really creating a lot of questions to software developers.
But this is not really something that existed before so this is the reason why it creates a lot of debates. With the MDD 93/42/EC, the idea of software as a Medical Device was not so popular. But now, all is software so this was a good reason to update that.
Cyrille Michaud from MD101 Consulting will help us understand this rule and the differences with the directive. He is a software developer so it's his specialty to help us solve those issues.
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.
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Links from the Video
■ MD101 Consulting website: www.md101consulting.com
■ MD101 Consulting Linkedin Page:
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■ Cyrille Michaud Linkedin:
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■ Blog Cyrille Michaud: [ Ссылка ]
■ Rendez-Vous Expert Medtech: [ Ссылка ]
■ Episode 15 – MDR and IVDR with Erik Vollebregt: [ Ссылка ]
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Social Media to follow
Linkedin: [ Ссылка ]
Twitter: [ Ссылка ]
Pinterest: [ Ссылка ]
Instagram: [ Ссылка ]
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#medtech #medicaldevice #compliance
