Product/Service

Medical Device Service -- Europe

Source: Emergo Group, Inc.
Emergo Group offers a single, a combination or the total package of the following medical device services for Europe
Emergo Group offers a single, a combination or the total package of the following medical device services for Europe:

  • Product classification and identification of applicable standards
  • Risk assessment (EN 1441)
  • Complete testing facilities on sterility and bio-compatibility
  • Complete testing facilities on EMC and electrical safety
  • Verification and compilation of technical file and other CE product documentation
  • Preparation or editing of instructional manuals
    • Quality Systems - ISO 9000 / EN 46000 series
    • Training (on-site)
    • Implementation
    • Audit and Registration
  • Access to and final approval with Notified Body
  • Legal assistance in liability claims
  • Sales of European and international standards
  • Technical and legal handbooks and software on CE Marking for Medical Devices
  • Translation services for all European language requirements
  • Clinical research phase II, III and IV according to FDA and ICH/GCP guidelines
  • Medical scientific sales marketing support

    We welcome all inquiries and will be pleased to provide more detailed information on our services

    Emergo Group, Inc., 1684 East Gude Drive, #202, Rockville, MD 20850. Tel: 301-762-2828; Fax: 301-762-4043.