Obelis European Authorized Representative Center (O.E.A.R.C.) is a European-based consulting company providing European Authorized Representative and CE Marking services to non-European medical devices manufacturers under AIMD, MDD, and IVD European Directives. Obelis's fully integrated solutions include certification of ?Class I? medical devices and IVD medical devices, technical file management and incident reports to European competent authorities, initial marketing setup, and clinical-trial services. Since May 2, 2001, O.E.A.R.C. is 9001:2000 certified by Lloyd?s Register Quality.

The real problems of companies entering European markets are not caused by balance sheets but by ever more complicated laws and regulations that can strangle any product launch. OBELIS assumes all the duties in the critical regulatory field to assist medical device companies in and/or outside of Europe to import and sell their products in Europe.

The introductions of the new medical products laws [MPG] of August 2, 1994 and of the medical products directive 93/42/EEC of June 14, 1993 as well as the fast technological progress require checking of entrepreneurial concepts and implementation of new systems. This implementation is made much easier with the help of competent OBELIS consultants and OBELIS partners.

COMPREHENSIVE AND COMPLETE REGULATORY COMPLIANCE PORTFOLIO

• Consultancy Service:
  For all products in the area of medical devices. OBELIS can supply documentation for every step of the necessary registration (Europe) and provide a safety advisor to the German Medical Devices Act (Germany).

• Compliance Responsibility:
  Every company from a third-party country (including the USA) that imports into Europe has to provide a person responsible for Europe. OBELIS delivers the necessary service.

• Full Service Capability:
  Authorizations granted to OBELIS ensures competent delivery of solutions for all regulatory issues. Manufacturers, re-sellers in and/or outside Europe do not require anything else.

ANY COMPANY ANY SIZE

OBELIS consultants are proven experts in their area of specialization. Therefore OBELIS provides competent consulting services and guidance for companies of any size. This involves checking a product idea, product trials and all legal requirements. OBELIS's network and knowledge delivers customized solutions to any company large or small.

Many companies have difficulties fulfilling all requirements of the medical products directive 93/42/EEC of June 14, 1993 and of the medical products law [MPG] of August 2, 1994, or making sure that all requirements are fulfilled on their own would mean investing unreasonable amounts of time and money. The implementation of such complex laws is made much easier with the help of OBELIS.

The strategic orientation of OBELIS is such that all the client's products are established on the market for the long term. OBELIS delivers cost effective solutions designed for long-term success. Quick fixes become very expensive over time.

OBELIS assists a vast number of diverse clients in seemingly hopeless situations and has successfully established their products on the European market.

KEY CONTACT

Mr. Miguel Ohn
Project Manager

OBELIS S.A.
European Authorized Representative Center
Avenue de Tervueren 34, Suite 44
B-1040 Brussels
Belgium

Tel: +32.2.732.59.54
Fax : +32.2.732.60.03

Web Address: http://www.obelis.net

E-Address: miguel@obelis.net