Medical Device Registration in Germany, IVDs, CE marking, EU MDR

Freyr offer Regulatory services for Medical Device & IVDs that includes registration with EMA, licensing, EU-MDR Transition, Classification, Dossier Review, Compilation & Submission, CE mark & ISO 13485 certification, provides support to certify medical devices from TUV, DQS, DEKRA, SGS in Germany region

– Freyr Webpage Link –

Medical Device Registration in Germany

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
  • 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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