The Medical Device Directives require a manufacturer to have a European address on devices sold in Europe which bear the CE Marking. If a manufacturer does not have, or does not wish to use their European address, they must use their importer, distributor or Authorized Representative for a registered address. The Visual Consultancy Corporation offers Authorized Representative Services and specializes in tailoring the Services to meet a manufacturer's current and future needs, while providing independence from an importer or distributor. The Visual Consultancy Corporation European staff is proficient in communicating with Competent Authorities and Notified Bodies, and is familiar with the regulations and additional national requirements for all countries throughout Europe. In addition, Grayton Integrated Healthcare's extensive background in regulatory consulting positions our staff to cost-effectively assist a manufacturer in meeting EU and individual country regulatory requirements. The Visual Consultancy Corporation's Authorized Representative Services include: Using our registered address Ensuring compliance with Medical Device Directives Representing the manufacturer to Competent Authorities and Notified Bodies Verifying the CE Marking is correctly affixed Managing incident reporting to Competent Authorities with required follow-up Initiating Conformity Assessment procedures and submitting application to a Notified Body Notifying Competent Authorities of, and managing, clinical trials