Materiovigilance

Materiovigilance

Medical Device or Diagnostic Vigilance, as Known as Materiovigilance. Medicines and Medical Devices have their own Unique Regulatory processes; Our Primary Purpose is to Protect and Improve Safety Risk Management for Patients by Collection, Assessment, Reporting and Identification of Trends in Incidents Resulting from the Use of Medical Devices.

Our Expertise

  • Medical Assessment & Case Narratives
  • Device Vigilance Report Preparation and Submission
  • Literature Search and Digital Media Monitoring Search
  • Post-Market Surveillance Reports (PMSR/PSUR)
  • ADE/MDI Trending and Evaluation & Reconciliation
  • Monthly Compliance and Status Reporting