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 8 integrated deliverables:
Assessment Framework
The scoring tool your team uses to evaluate each dimension.
Scoring Rubric
Level definitions and evidence criteria for every dimension.
Heatmap Template
Visual maturity snapshot — color-coded at a glance.
Delta Map Template
Current vs. target gap analysis for every dimension.
Methodology Guide
How to run the assessment — preparation, scoring, follow-up.
Benchmark Reference
Industry context for interpreting your scores.
Cross-Functional Team Guide
Who to involve and how to facilitate.
Executive Readout Template
Present findings to leadership.
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.