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ISO 13485:2016 Simplified

How to build your QMS system according to ISO 13485:2016 for medical devices 

What's included, and intention of module

One Video is included in this module, where you will learn about ISO 13485:2016, the difference between this standard and MDR, IVDR. You will also get information about each section in the standard and what does it mean for a IVD/medical device developer or manufacturer.


Introduction to 

ISO 13485:2016 for medical devices

Flying start

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Meet the instructor

Soha Sweilam

Soha Sweilam is the Quality Manager at ZP
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