MDR VS MDD: WHAT YOU NEED TO KNOW

MDR VS MDD: WHAT YOU NEED TO KNOW

The Medical Device Directive (MDD) has governed medical device regulation within the European Union since its inception in 1993. However, the evolution of technology and the healthcare landscape has rendered the MDD outdated. Consequently, a pressing necessity arises...
FAQ: HOW CAN I open My Certificate?

FAQ: HOW CAN I open My Certificate?

This month’s frequently asked question: Why can’t I open my certificate?   With the upcoming ICH GCP R3 update, and the need for innovative and up-to-date training, it’s also essential to have access to your certificates, and know how long they’re valid...
FAQ: Transition to EU CTR – No need to panic!

FAQ: Transition to EU CTR – No need to panic!

We are getting more and more questions about the EU CTR. The transition period is about to end, and we ‘re noticing it. That’s why we would like to share with you the most critical issues: The Clinical Trials Regulation (Regulation (EU) No 536/2014) or, in short, the...