Define clinical data collection strategy addressing evidence gaps and confirming real-world performance.
Activity | Description | Aim | Timeline |
---|---|---|---|
PMCF-001 | Multi-site registry study | Validate diagnostic accuracy in 5,000 diverse patients | 24 months |
PMCF-002 | Healthcare provider survey | Assess workflow integration and usability | 12 months |
PMCF-003 | Literature surveillance | Monitor published data on AI diagnostic tools | Ongoing |
PMCF-004 | Algorithm performance monitoring | Track diagnostic metrics through device telemetry | Ongoing |
What types of PMCF activities should we plan?
How do we determine if our device requires PMCF activities?
What should we do if PMCF activities identify new safety concerns?
How often should we update our PMCF plan?
Can we use real-world data for PMCF activities?