Medical Device Consulting Services for EU

Whether you’re entering the EU market for the first time, or introducing another device, we can assist with everything from ISO 13485: 2003 Quality System compliance and audits to Design Dossiers and even conducting Clinical Trials.

From advising you on which EU Directives will apply to achieving CE markings, our team of experts can advise you on the appropriate device classification and related regulation and registration requirements, and support the implementation of a quality management system that complies with ISO requirements.

We can also act as a regulatory Authorized Representative to non EU manufacturers without a local office in an EU member state.

Provisional Regulatory Services by Authorized EU Regulation Specialist

  • Medical Device specific regulation strategy reports
  • ISO 13485 Quality System Implementation consulting
  • ISO 13485 Auditing
  • Authorized Representative (EC REP)
  • CE Marking Consulting for Medical Devices and IVD
  • Technical File Preparation for Medical Devices and IVD
  • Clinical Trial Management for Medical Devices in Europe
  • Medical Device Directives and CE Mark Training
  • EU Medical Device Reimbursement
  • Risk Management and Risk Assessment consulting