Obelis European Authorized Representatives Center (O.E.A.R.C.) is a quality driven, service oriented company with over 20 years of experience with European Regulation. Obelis operates as one of the largest regulatory centers in Europe today, providing CE marking & Authorized Representative services for Medical Devices, In-Vitro Diagnostics as well as “EU Responsible Person” and Cosmetic Notification services in Europe.
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 – such as medical devices, in-vitro diagnostics, machinery, personal protective equipment, pressure equipment, radio and telecommunication equipment, electrical equipment, low voltage equipments, cosmetics, toys and many more).
Obelis is a veteran member of the E.A.A.R ( the European Association of Authorized Representatives).Obelis is active within the EU commission major committees (Medical Device Vigilance committee and IVD Technical committee, Cosmetic Annex I Committee and more) - providing its clients and collaborators with the directions of the Commission before hand.
Specialties
Medical Devices, In-Vitro Diagnostics, Cosmetics, Authorized Representative / Responsible Person, CE Marking, Free Sales Certificate, GMDN Code Verification, Post-Market Surveillance, CE Certification, R&TTE Directive
New hires at Obelis s.a.
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Regulatory and Notification Intern
Came from...
Western Union, Communication Officer
Obelis s.a. Activity on LinkedIn
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Obelis s.a. has a new Regulatory and Notification Department
Paressa Plataki is now Regulatory and Notification Department
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