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.