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News
What is new in the European Standardisation system?
To modernise the European Standardisation System, the European Commission proposed to amend the Standardisation Regulation as part of its European Standardisation Strategy of February 2, 2022. Read all the details in our article!
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!
Obelis group awarded as Great Place to Work 2022!
Investing in our employees is of paramount importance to us. We are more than honored to be awarded as Great Place to Work 2022!
European Authorised Representative (EAR) for manufacturers based in Turkey
There are few direct implications to the Customes Agreements for manufacturer of medical devices from Turkey. Read all the details in our article!
New Proposal from the EU Commission for a Cyber Resilience Act
European Commission presented a proposal for a Regulation on cybersecurity requirements for products. Read more!
Webinar: EU- UK GDPR Requirements & Implementation
Discover the new GDPR obligations for businesses and organizations within the EU and UK!
The Italian National Registration for Breast Implants – Results of the pilot phase
Find all data collected and results from the Italian National Registration for Breast Implants pilot phase. Read it now!
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!
EU addresses microplastics issue with regulation proposal
The European Commission issued a proposal to restrict microplastics. The regulation will have an impact on products containing those substances. Read more!