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It's not easy to classify a Medical Device. You need to have all the device features and intended purpose to really determine its classification.
In this video, I will show you some examples and you'll have to find the answer.
I will also provide you with different technics that were used with MDD 93/42/EC and may still be applicable for MDR 2017/745.
I create a free classification form that you can download at easymedicaldev...
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...
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► Links from the Video
■ Blog Post - Medical Device Classification: easymedicaldev...
■ Presentation download: mailchi.mp/eas...
■ Borderline manual: ec.europa.eu/d...
■ Meddev 2.4/1 rev 9: ec.europa.eu/Do...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#medtech #medicaldevice #compliance