Resources · Decision Kit
The MedTech Evidence Gap-to-PMCF Decision Kit.
Turn clinical evidence gaps into actionable post-market evidence plans.
The MedTech Evidence Gap-to-PMCF Decision Kit provides a structured approach to evaluating clinical evidence gaps and developing defensible evidence-generation plans — connecting clinical claims, residual risks and existing evidence with appropriate PMCF methods, data requirements and reporting workflows.
16 pages · 4 worksheets · 90-day roadmap
Read the complete PDFEducational planning aid. Not a substitute for device-specific regulatory, clinical, statistical or legal review.
Inside the decision kit
Is your MedTech organization struggling to determine…
- Whether its existing clinical evidence is sufficient
- Which evidence gaps require attention
- Whether a registry, survey, observational study or another PMCF activity is appropriate
What you'll receive
A comprehensive 16-page implementation guide with an evidence-gap assessment worksheet, a PMCF study-planning template and a practical 90-day implementation roadmap.
- Claim-to-evidence gap matrix
- Evidence method selector
- PMCF study brief
- RWD fitness-for-purpose checklist
- 90-day roadmap
- 12-point PMCF plan review
Ideal for
MedTech teams in
- Regulatory Affairs
- Clinical Affairs
- Medical Affairs
- Quality
- RWE
- Product leadership