An interview with Sarah You about her experience in following one of our expert’s professional trainings on EU Regulations and the insights she gained from it.
In-vitro diagnostics regulation (IVDR)
Webinar: EUDAMED Actor & Device registration
Register and learn all the details about EUDAMED, the European database for medical devices and In-vitro diagnostics!!
Seminar: Placing Medical Devices and In-Vitro Diagnostic Devices on the Union Market (EU) – News and Challenges
Register for our new live webinar about MDR and IVDR! On December 19, at 3:00 pm (Beijing Time), in collaboration with TÜV SÜD and AKRA TEAM GmbH!
Post-Market Surveillance (PMS) and Vigilance: definitions and differences
Vigilance and Post-Market Surveillance definition, differences and their scope. Visit our webpage for all the details!
Webinar: IVDR vs IvDO
Join our latest Webinar about the EU IVDR vs. the Swiss IVDO.
Watch the recording to discover all the details from our expert!
EU IVDR now applies in Europe:What should IVD manufacturers do to comply?
If you are unsure of how you should now proceed in order to import new devices or maintain the previous ones in the European territory, this webinar is what you were looking for! Register now!
IVDR Webinar: Complying with the IVDR Legacy Requirements
Join our latest Webinar about IVDR. Davide Turchi, Manager of the Regulatory Affairs department at Obelis Group, will walk you through all the challenges related to Legacy Requirements!
EU list of recommended antigen COVID-19 test replaces Belgian list
Antigen tests are IVDs of class D under the IVDR. This means that they will fall under the highest-risk category of IVDs, needing a Notified Body involvement.
Obelis Roundtable on IVDR: How to get ready?
While every In Vitro Diagnostics brand journey, mission and merchandise are different, the regulatory compliance…
LIVE Roundtable: IVDR is coming- how to get ready!
Don’t miss this unique opportunity to learn suggested strategies and best practices that lead to successful IVDR transition and outcomes!