 |
|
EU and US Representation
European Authorized Representative
The European Medical Device Directives require every medical device manufacturer that does not have a legal presence in the EU to appoint an 'Authorized Representative' to act as a focal point for communication with Competent Authorities on safety issues.
To maintain the independence from distributors and importers, many companies prefer to use VISAMED as European Authorized Representative (EAR). Furthermore, having one EAR as a central point to the government authorities in the European union member state will result in effective communication and favorable outcome for your business.
We see our EAR service as a central component of the overall service we offer to our clients.
U.S. AGENT
Any foreign establishment engaged in the manufacture, preparation, coupounding or processing of a medical device imported into the Unites States must identify a United States agent (U.S. Agent) for that establishment. VISAMED’s US partners offer US Agent services.
We have proven our capability in a multinational environment to effectively relate requirements of the U.S. Food and Drug Administration to our clients.
In addition to the basic fundamental service as U.S. Agent, we offer a variety of services that can be tailored to fit the needs of our clients.
The services provided are listed below:
 Annual Basic Representation
Annual Facility Registration & Listings
Medical Device Reporting Complaint Handling Management
|
|
Tel. +49(0)721-4764847