Post-Market Data
Post-market surveillance
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.
Site capture forms
Configured clinician and secretary forms for baseline demographics, imaging metrics, and procedure details - alongside patient ePRO in one audit trail.
Export-ready summaries
Aggregated safety and performance data with published reference context where configured - ready for PMCF evaluation and periodic reports.
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 with patient-friendly re-engagement - high completion rates are the PMCF differentiator, not EDC feature parity.
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
- ✓ Configured site capture for baseline clinical and imaging data where your plan requires it
- ✓ Published literature reference bands for common PROMs in analytics (where configured)
- ✓ Aggregated exports with a full audit trail
- ✓ Adverse event capture wired into your safety reporting workflow
Patient Watch is capture software for longitudinal PRO and configured site forms - not a full Medidata-style eCRF or CTMS. That is usually the right fit for PMCF; qualify early if your sponsor requires query management and SDV.
Case Study
Otivio FlowOx - multi-market MS surveillance
Target go-live: July 2026
Patient Watch is building the digital follow-up layer for FlowOx home therapy in Denmark (Bandasjist) and Germany (OxyCare). Patients complete MSIS-29 plus market-specific tracking - PSFS in Denmark and NRS in Germany - with automated reminders in Danish and German.
- • Baseline and 4-week MSIS-29 milestones, then ongoing monitoring for continuing use
- • QR or invite onboarding, consent, prescription upload and training confirmation before first assessment
- • Clinician caseload views and downloadable progress reports for Bandasjist and German distributor sites
- • Aggregated post-market exports for Otivio across both countries
Ask us about post-market capture for a home-use device with multi-country distributor networks.
Plan your programme with us
Tell us about your device and follow-up plan and we'll scope what capture should look like.