Regulatory compliance

Regulatory Compliance

Vantage Quality help medical device manufacturers obtain CE Marking in Europe. Our European medical device consultants can assist you with a wide variety of regulatory and quality assurance issues as shown below. Areas we can support you in include:

  • Device Registration
  • European CE Marking for Medical Devices
  • EU CE Marking Technical File or Design Dossier Compilation
  • STED - Summary Technical Document Preparation
  • CE Mark Training at Your Facility
  • European Medical Device Classification
  • ISO 14971 Risk Management activities
  • On-Site Group ISO 14971 Training
  • Regulatory consulting for medical device software and mobile apps

Contact Us to discuss you needs.