European Authorized Representative Center

European Authorized Representative
   
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Obelis O.E.A.R.C. Provided Services



Eaar Member
EAAR MEMBER

ISO 9001:2001
ISO 9001:2001

Obelis European Authorized Representative Provided Services

 

O.E.A.R.C. covered Directives


Medical Device Directive 93/42/EEC


In Vitro Device Directive 98/79/EC


Personal Protective Equipment 89/686/EEC


Low Voltage Directive 73/23/EC


Electromagnetic Compatibility 89/336/EEC


Cosmetic 78/768/EEC


General Product Safety 2001/95/EC


Machinery Directive 98/37/EC


Toy Safety Directive 88/378/EEC

Services Provided by O.E.A.R.C.


E.A. Representation


Environmental Directives


Packaging & Packaging Waste 94/62/EC


Clinical Investigations


Post Market Surveillance (P.M.S.)


O.D.R.P.


Call Center




International Services

USAgent


OneLink:OneSolution™

As part of our commitment to quality and service, Obelis European Authorized Representative Center has created the OneLink:OneSolution™ network that includes more than a dozen partner firms in eleven countries that offer complimentary services.

The OneLink:OneSolution™ team includes top consultants, translation services, and regulatory assistance, as well as many other services in Australia, Brazil, Canada, China, the European Union, India, Israel, Korea, Malaysia, and the United States. Each of these firms work together to assist companies in reaching the different markets faster and easier, as well as working on their own local level to adapt your product and needs to that particular market, language, and culture.


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