Post-Market Surveillance (PMS)
Proactive monitoring to ensure continued safety and performance in the real world.
What We Do
Regulatory responsibility doesn't end at launch. We help you build a proactive PMS system that meets the rigorous requirements of EU MDR and FDA, turning data into actionable insights.
- PMS Plans: Comprehensive strategies for collecting and analyzing post-market data.
- Post-Market Clinical Follow-up (PMCF): Surveys and studies to close clinical data gaps.
- Periodic Safety Update Reports (PSUR): Comprehensive safety summaries for higher-class devices.
- Vigilance Reporting: Support for adverse event reporting and recalls.
Deliverables
PMS Plan & Report
PMCF Plan & Report
PSUR / PBRER
Complaint Handling SOPs