Post-Market Surveillance That Keeps You Compliant
Post-Market Surveillance (PMS) systems and vigilance procedures that work after launch — not just on paper.
Scope
What’s Included
- PMS plan
- Post-Market Clinical Follow-up (PMCF) plan where required
- Vigilance system and procedures
- Trend analysis and reporting
- Periodic Safety Update Report (PSUR) preparation
- Complaint and feedback system
- Corrective action processes
Fit
Who It’s For
- Manufacturers approaching their first placing on the market
- PMS systems needing alignment with MDR 2017/745
- Portfolios with growing field data to manage
Deliverables
What You Receive
- Documented PMS system and procedures
- PMCF plan where applicable
- Reporting templates
- PSUR template and instructions
Limits
What’s Not Included
- Conducting PMCF studies — clinical execution runs with your clinical partners
- Day-to-day complaint handling — that stays an operational process of yours; the system makes it manageable
- Continuous literature monitoring — available as an ongoing arrangement
Timing
Indicative Timelines
Typically 4–8 weeks to a documented system, depending on portfolio and existing procedures.
Ready to Set Up Your PMS?
Free initial consultation · Response within 24 hours · No obligation
Regulatory information last reviewed: 10 August 2026