Medical Device Regulatory Services in France

Freyr has dedicated expertise for supporting device manufacturers in obtaining CE marking. Our experts assist in device classification, product notification/registration, technical file preparation, etc. in compliance with the EU and ANSM regulations for successful device approval and market-entry.

Check out more at: Medical Device Regulatory Services in France

Freyr Expertise

  • European Medical Device Classification
  • ISO 13485 Compliance
  • CE Technical File or Design Dossier Review, Compilation and Submission
  • EU-MDR Transition and Support
  • Clinical Evaluation Reports (CER) for Medical Devices
  • Notification/Registration of Medical Devices with ANSM
  • Registration of Foreign Medical Device Manufacturers in France
  • ISO 14971 Risk Management Consulting
  • Medical Device Regulatory Strategy Report
  • Testing Support- Biocompatibility, Electrical Safety and Mechanical & Performance
  • Labeling and GMP Support
  • Post-market Monitoring and Adverse Event Reporting
  • European Authorized Representative Support

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