Post Market Surveillance
PMS, PMCF and PSUR - one tool
Gather adverse events, PROMs and real-world performance data for your MDR Post Market Surveillance and PMCF plans. Built for medical device manufacturers who need defensible, structured evidence.
What's included
From device launch to PSUR
Adverse event capture
Patients flag adverse events directly through their diary - routed to your safety team in real time.
Continuous PROMs
Validated outcome measures collected at the intervals your PMCF plan requires - without manual chasing.
PSUR-ready exports
Aggregated safety and performance data in the format your Notified Body and PSUR review expects.
Pre-defined PMCF plan
We help you align endpoints, sample sizes and frequencies with your MDR PMCF plan from day one.
GDPR and ISO 13485 aligned
Hosted in the EU, pseudonymised by default, with audit trails and quality processes that survive an inspection.
Long-term follow-up
Multi-year follow-up windows with patient-friendly re-engagement - so cohorts don't fall off after year one.
Designed for MDR submissions
Aligned with the EU MDR PMCF requirements and built around what Notified Bodies actually ask for.
- ✓ Patient-reported safety, performance and quality of life endpoints
- ✓ Pre-defined collection schedule per MDR PMCF plan
- ✓ Aggregated PSUR-ready outputs with full audit trail
- ✓ Adverse event capture wired into your safety reporting workflow
Plan your PMCF with us
Tell us about your device classification and PMCF plan and we'll scope a programme that meets MDR expectations.