Clinical Evaluation Report
- Clinical evaluation planning
- Literature search and screening
- Data extraction and appraisal support
- Clinical evidence and claims traceability
- Update planning
Clinical evidence & lifecycle safety
Connect clinical evidence, risk management, and post-market feedback.
Documentation support to help manufacturers assess available evidence, document risks and benefits, and plan lifecycle monitoring appropriate to the device and applicable requirements.
Risk management
- ISO 14971 file review
- Hazard identification and risk estimation support
- Risk control traceability
- Residual risk and benefit-risk documentation
- Production and post-production inputs
PMS, PMCF & PSUR
- PMS plan and report support
- PMCF plan / evaluation documentation where applicable
- PSUR support where required
- Complaint and trend input review
- Feedback into risk and clinical evaluation
Evidence-led, not template-led.
Document content and conclusions should reflect the actual device, intended purpose, available clinical and non-clinical evidence, relevant state of the art, and applicable regulatory expectations. Missing evidence should be identified rather than assumed.
Common deliverables
- Literature search strategy and screening log
- Clinical evidence appraisal tables
- Clinical evaluation plan / report support
- Risk management review and traceability matrix
- PMS plan and report templates tailored to scope
- PMCF and PSUR documentation support where applicable
- Action list for evidence gaps and lifecycle updates