Obelis European Authorized Representatives Center (O.E.A.R.C.) is a quality-driven and service-oriented company with over 25 years of experience in European directives and regulations. We provide European Authorized Representative services and « EU Responsible Person » services for both non-EU and EU manufacturers.
In addition, Obelis is one of the largest regulatory centers in Europe today, offering CE marking consulting services and Authorized Representative services for medical devices, in vitro diagnostics, and other New Approach directives (aimed at CE marking). We also provide « EU Responsible Person » services for the cosmetics industry. While maintaining particular expertise in Medical Devices & Cosmetics, Obelis’ services cover most of the European New Approach Directives (Directives requiring either CE marking or an Authorized Representative).
Committed to the highest level of quality services, since May 2001, O.E.A.R.C. has been certified according to ISO 9001:2008, with the addition of the ISO 13485:2003 certificate starting from April 2012.
As one of the founding members of the E.A.A.R. (European Association of Authorized Representatives) and ERPA (European Cosmetics Responsible Person Association), Obelis continues to be an active member of professional associations at the European level and participates in various committees at the European Commission level.
Thanks to its proven expertise and reputation in the regulatory field, Obelis was invited by the University of Galway, Ireland, to join a consortium of five partners—one university and four SMEs including Obelis—to work on an FP7 health-related project (NeuroGraft). Obelis is also a regulatory consulting partner in an H2020 project called GLAM (« Glass – Laser Multiplexed Biosensor »), coordinated by the Leitat Technological Center.
