News & Insights


New European Medical Device and IVD Regulation – Where is it?

The long anticipated wait for agreement and adoption of the new European Medical Device and IVD Regulations will go on… Read more

In Vitro Diagnostic Medical Device Regulations Acorn Regulatory

Borderline Medical Devices Covered in EU Manual Update

With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly… Read more

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