European Authorized Representative
Polmed.de is a German company that offers consulting services on quality and legal compliance for international manufacturers of medical devices and diagnostic products in vitro.
Our company deals with issues related to the quality management system, legal regulations, product documentation, the process of accreditation, certification CE, as well as services in the field of EU representation for manufacturers of medical devices as the European Authorized Representative according to the requirements of the:
- Medical Devices Directive MDD 93/42/EEC
- Active Implantable Medical Devices Directive AIMDD90/385/EEC
- In Vitro Diagnostic Medical Devices Directive IVD98/79/EC
Polmed.de is ready to take on the responsibilities of your Authorized Representative in the European Union, in accordance with Directives MDD and IVDD.
Our comprehensive and high quality services ensure a CE mark of conformity with the requirements of the directives.
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