Vigilance for Medical Devices

We offer you

  • Compliance with guidelines on the Medical Device Vigilance System
  • Adverse incident assessment and management process
  • Reporting of adverse incidents
  • Preparation and management of Field Safety Corrective Action (FSCA)
  • Preparation and management of Field safety notice (FSN)
  • Periodic summary reporting
  • Establishing a quality system
  • Preparation of Standard operating procedures
  • Monitoring of Compliance
  • Setting up appropriate Contractual arrangements and supervision