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...
New information on expert panels published
The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies...
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...