Post-Market Surveillance CMM
Assess and mature your post-market surveillance program.
What this assessment evaluates
This assessment evaluates your post-market surveillance across 8 dimensions:
- PMS Planning & Strategy
- Data Source Identification
- Data Collection & Aggregation
- Signal Detection & Trending
- Periodic Safety Update Reports (PSUR)
- Regulatory Reporting Triggers
- Feedback Loop to Design & Risk
- PMS Report & Documentation
Who it's for
Regulatory and quality teams building or upgrading post-market surveillance under EU MDR or FDA requirements.
About this assessment
Evaluate your PMS across 8 dimensions — from data source identification through signal detection, PSUR generation, and feedback loops to design and risk.
What you get
Every assessment includes 5 integrated deliverables:
Assessment Workbook
Maturity model with scoring rubric and regulatory bridge.
Heatmap & Insights Workbook
Multi-entity analytics, entity profiles, cycle comparison, and action register.
Methodology Guide
Step-by-step assessment planning and execution.
Benchmark Reference
Industry context for interpreting your scores.
Executive Readout Template
Board/leadership presentation template.
How it works
Purchase & download
Get your complete assessment package immediately after checkout.
Score with your team
Assemble your cross-functional team and score each dimension together.
Present & prioritize
Use the heatmap and executive readout to present findings and build your improvement roadmap.