Obelis (O.E.A.R.C.) is a quality driven, service oriented company dedicated to assist non-European and non-US medical device manufacturers' successful endeavor into Europe and the United States.
In February 1996, in response to the EEC requirements for non-European manufacturers to appoint a European Authorized Representative, Obelis s.a created the European Authorized Representative Center, OEARC.
Obelis is an international company based in Brussels, Belgium since 1988. We have 17 years experience giving Commercial, Regulatory, Administration, and Market development services.
We are located at walking distance from the EEC Headquarters, maintaining close and personal relations with the EU Administration.
We are committed to maintaining the highest level of quality and services, thus since May, 2001 Obelis is ISO 9001:2000 compliant company Certificate number 01121 by Lloyd's Register) , although incorporation of the ISO standards is not compulsory.
In November 2001 the US Food & Drug Administration (FDA) published a new regulation requiring every non-US manufacturer of drugs and medical devices to appoint a US Agent. Obelis' US Agent office in Claremont, NH has been created in response to the new FDA requirement.
Today Obelis is one of the most important European Authorized Representative Centers in Europe, and is an active member of the E.A.A.R (European Association of Authorized Representative).
We maintain a proven international reputation among clients in North America, the Far East & Middle East. |
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