Second Corrigendum to the MDR and IVDR

This update gives certain Class I manufacturer a break. On December 27 the second corrigendum was published in the official Journal of the EU. This up...

Another update on UK guidance!

Published September 3. We will review this new update and check whether it effects our Responsible Person (RP) contract and update accordingly if need...

It`s about time…

It is about time to start YOUR MDR/IVDR project. Even though the whole world is lamenting about the new Medical Device Regulation (MDR) and In-vitro D...

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