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Understanding the CE Marking process for In Vitro Medical Devices – 1 day course

What you will know by the end of the course:

The course will give you a wide understanding of the In Vitro Medical Device Directive (IVDD 98/79/EC), how it applies to your medical device application and what will need to change in preparation for the new Regulation (IVDR (EU) 2017/746).

Following the course, you will understand how to fulfil the Essential Requirements and how to create a compliant product Technical File.


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