OBELIS S.A.

BRIEF DESCRIPTION OF THE ORGANIZATION

Obelis is one of the largest Regulatory Centres in Europe, assisting non-European and European manufacturers of medical devices, in-vitro diagnostic medical devices, and other health-related products in their successful endeavours in Europe. For more than 30 years, we have been dedicated to helping regulators improve legislation and standards, thanks to our practical experience consulting with manufacturers and researchers.

Our staff has extensive experience participating in EC expert working groups, including the Medical Device Coordinator Group (MDCG)  shaping the EU regulatory landscape.

WHAT IS YOUR ROLE IN THE PROJECT?

Obelis is one of Europe’s leading specialists in EU regulations and will define a solid regulatory pathway to guide pre-clinical approvals (IMP) and future clinical requirements.