One struggle for Medical Device manufacturers when they are working on their CER or Clinical Evaluation Reports is to prove product equivalence. So to help I invited Helene Quie on the Podcast.
Imagine that you have no clinical data for your product and you want to use the data obtained from another product. This would be great. But before that you need to prove that your product is equivalent to the other one.
With the new MDR 2017/745, the mindset is changing. Notified Bodies are going more in-depth and this is why Helene Quie from Qmed Consulting is helping us to understand how to answer this question.
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Links from the Video
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Social Media to follow
Linkedin: / melazzouzi
Twitter: / elazzouzim
Pinterest: / easymedical. .
Instagram: / easymedical. .
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#medtech #medicaldevice #compliance
Негізгі бет How to perform Product Equivalence on your CER (Clinical Evaluation Report)?
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