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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

General medical devices and equipment


We help medical device companies of all sizes get CE marking under the European Medical Device Regulation.



Our services for CE marking under MDR cover all risk classes and include:

  • Regulatory strategy development.
  • Gap analysis and audit readiness assessment.
  • Technical file preparation
  • Risk management implementation.
  • Clinical evaluation support.
  • Labeling and packaging compliance.
  • Post-market surveillance (PMS) guidance.
  • Interaction with Notified Bodies.
  • Training and education.
  • Ongoing support and compliance monitoring

360° CE Marking Services for General Medical Devices and Equipment of all Types and Classes


We offer complete CE marking services for all types and classes of medical devices and equipment, whether it's a simple diagnostic device or a complex surgical instrument.

Contact us today to learn more about our tailored services and how we can support your journey towards CE certification under MDR.

Send us an email:
info@mdrc-services.com

Or use the contact form below