Online course

Post-Market Surveillance Requirements for Medical Devices

10 modules · 3h 22 of video · downloadable transcripts · certificate on completion

What the course covers

  1. Introduction
  2. PMS system and PMS plan
  3. Complaint handling process
  4. Vigilance reporting: criteria and timelines
  5. Vigilance reporting: MIR, IMDRF codes and other jurisdictions
  6. Trend reporting, serious incidents and field safety actions
  7. Post-market clinical follow-up
  8. PSUR and PMS report
  9. Post-market risk management
  10. PMS in audit and inspection

The first module is free to watch — no account needed. Start it now →