CIMS services within the Medical Device Regulation

  • QMS development
  • Audit
    • 3rd party assessment
  • Technical File development
  • Authorised representative build
    • Documentation management
    • Data Management
    • Vigilances
  • MDR conformity assessment
  • Heath Authorities communication
  • CE Marking
  • Clinical Development
    • PMCF
    • Evaluation
    • Investigation
    • Data Management
    • CRO Management

Services post CE-marking

  • GCP storage of MD files, documents data
    • End market storage(10, 15 years)
  • Data Management services
  • Post Marked
  • Regulatory compliances
  • Acting Authorised representative
  • Post-market
    • Surveillance
    • Vigilances
    • Market surveillance
  • PMCF
  • PSUR
  • Statistical services