Our Services:

• we represent our clients before the European Commission and National Competent Authorities;
• we supervise the product, monitor accidents appearing as the result of using the medical device (Incident Reporting) and we present Advisory Notices;
• we verify and classify the product;
• we register the Class I products at the EU Authorities;
• we assist to implement quality systems which are proper for your products;
• we fulfill a function of „Safety Officer” in Germany and other countries;
• we give advice on the technical documentary’s being in accordance with the basic requirements, we label and make risk analysis;
• we store your Declarations of Conformity and your technical documentation to make them accessible to EU Authorities;
• we notice changes in the European law and we create strategies which let your company adapt to it.

Additional Services:

Free Sale Certificate        

       Polmed.de as Your Authorized Representative may obtain

     a Free Sale Certificate for any non European country

Registration of medical devices

Polmed.de as the Authorized European Representative register your  medical devices with the Competent  Authorities in Europe