Vigilance for Medical Devices

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Vigilance for Medical Devices

OUR SERVICES

  • Compliance with guidelines on the Medical Device Vigilance System
  • Person responsible for regulatory compliance (PRRC)
  • Establishing a quality system and training of personnel
  • Post-market surveillance system
  • Assessment of incidents and events
  • Reporting of incidents and other events
  • Preparation and reporting of Field Safety Corrective Action (FSCA)
  • Preparation of Field safety notice (FSN)
  • Preparation of Periodic safety update reports
  • Setting up appropriate contractual arrangements and supervision
  • Audits and pre-inspection consultations
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER