Obelis European Authorized Representatives Center (O.E.A.R.C.) is a quality driven, service oriented company with over 25 years of experience with European Directives & Regulations, providing European Authorized Representative services and “EU Responsible Person” services aimed at Non-EU & EU Manufacturers.
Additionally, Obelis operates as one of the largest regulatory centres in Europe today, providing CE marking advisory services & Authorized Representative services for Medical Devices, In-Vitro Diagnostics and other NEW Approach Directives (aimed at the CE marking) as well as “EU Responsible Person” aimed at Cosmetic services. While still retaining a special expertise in Medical Devices & Cosmetics, Obelis services cover most of the NEW Approach European Directives (Directives requiring either a CE marking or authorized representative).
Committed to the highest level of quality services, since May, 2001, O.E.A.R.C. was certified according to ISO 9001:2008 with addition of the ISO 13485:2003 certificate as of April 2012.
As one of the founder members of E.A.A.R (European Association of Authorized Representative) & ERPA (European Cosmetics Responsible Person Association) Obelis continues to be an active member in professional associations on a European level and participates in different committees at EU Commission level.
Thanks to its proven expertise and reputation in the regulatory field, Obelis has been invited by the University of Galway, Ireland to join a consortium of 5 partners – 1 university and 4 SME’s companies including Obelis- to work within an FP7 health related project (NeuroGraft). Obelis is also a regulatory consultant partner in a H2020 project called GLAM (“Glass – Laser Multiplexed Biosensor”) coordinated by the Leitat Technological Center .