PHARMACOVIGILANCE

Vigilance for Medical Devices

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Vigilance for Medical Devices

WE OFFER YOU

  • Compliance with guidelines on the Medical Device Vigilance System
  • Person responsible for regulatory compliance (PRRC)
  • Establishing a quality 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
  • Setting up appropriate Contractual arrangements and supervision
  • Audits and Pre-inspection consultations
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OUR SERVICES - WE FORSEE AND ADAPT