Post-Market Data
Post-market surveillance
Monitor safety and performance after launch. Collect prospective patient follow-up and clinician feedback on real-world use - in one programme.
What's included
Follow-up from launch onwards
Adverse event capture
Patients flag adverse events directly through their diary - routed to your safety team in real time.
Continuous PROMs
Validated outcome measures from patients on the schedule in your approved follow-up plan - without manual chasing.
Clinician surveys
Ask clinicians who use your device in practice about ease of application, technique and training - including cases they have already treated, where your plan allows.
Export-ready summaries
Aggregated safety and performance data you can use in periodic safety reports and regulatory submissions.
Aligned to your follow-up plan
We configure questionnaires, sample sizes and schedules to match your approved post-market plan - not a generic template.
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.
Built for regulated follow-up
EU MDR expects evidence from patients and from the clinicians who use your device. We support both in one programme.
- ✓ Prospective patient follow-up on safety, performance and quality of life
- ✓ Clinician surveys on real-world use - ease of application, technique and training
- ✓ Pre-defined collection schedule matched to your follow-up plan
- ✓ Aggregated exports with a full audit trail
- ✓ Adverse event capture wired into your safety reporting workflow
Plan your programme with us
Tell us about your device and follow-up plan and we'll scope what capture should look like.