Client journey
From first conversation to a defensible PMCF report
What happens when a registry starts on EvidenceOS: how you sign up, what the registry collects, and which regulatory obligations the resulting evidence answers.
Step by step
How a registry signs up and goes live
Six stages, typically four to six weeks from agreement to first patient entered.
- 1
Week 1
Scope the registry
You tell us the device family, the indication, the participating sites and the questions the registry has to answer — PMCF, a society registry, a post-market study or a sponsor-funded outcomes programme. We map that onto the universal registry engine and the specialty pack (orthopedic and spinal implants ships first).
- Registry charter and objectives agreed
- Specialty pack and data dictionary selected
- Site list and sponsor / society roles defined
- 2
Week 1–2
Sign up and provision the tenant
Subscribe online for Registry or Evidence Program, or request a quote for a consortium. Your organisation tenant is created with your own account as owner; you invite colleagues and assign roles. Every record from this point forward carries an audit trail.
- Organisation tenant with your own sign-in
- Owner, admin and member roles assigned
- Part 11-ready audit trail and e-signature enabled
- 3
Week 2–3
Configure the data set
Outcome instruments, visit windows, device attributes and consent language are configuration, not a software project. Standard instruments (ODI, VAS, EQ-5D and the specialty set) are prebuilt; custom fields are added within the agreed limits.
- Visit schedule with due windows
- Outcome instruments and scoring rules
- Device / UDI attributes pulled from AccessGUDID
- 4
Week 3–6
Onboard sites and start entering data
Sites are invited by email into a free, de-identified site portal — coordinators and investigators enter procedures, implants, follow-up visits and safety events without needing a licence of their own. Identifiers stay at the site; the registry holds coded records.
- Site invitations and delegated permissions
- Free investigator and coordinator workspace
- De-identified data capture with query workflow
- 5
Ongoing
Run the registry
Follow-up clocks, overdue-visit alerts and safety triage run automatically. Your Evidence KPIs page shows enrolment, follow-up compliance, patient-reported outcome change, implant survivorship and open safety signals across every registry.
- Follow-up compliance and overdue visit tracking
- Serious / device-related event escalation
- Cohort and survivorship analytics
- 6
Annually or on demand
Produce the evidence
The PMCF / registry report is generated from live data — not rebuilt in Word — with CSV export for statisticians and a print/PDF version for the notified body, the sponsor board or the society. An inspection-readiness pack assembles the supporting record history.
- PMCF / registry annual report
- Controlled de-identified data export
- Inspection-readiness pack with signatures
Data set
What the registry actually collects
De-identified by design: direct identifiers stay at the site, the registry holds coded records.
Participants
- Coded participant identifier and enrolment status
- Consent record, version and date
- Demographics limited to what the analysis needs (age band, sex)
- Withdrawal and lost-to-follow-up reasons
No direct identifiers are stored in the registry; the site keeps the linking key.
Procedures and devices
- Procedure type, date, site and operating surgeon role
- Levels / anatomy and approach for orthopedic and spinal implants
- Every implanted component: manufacturer, brand, model, lot, UDI-DI
- Explant and revision records with reason codes
Device attributes are pulled from AccessGUDID so catalogue data is not re-keyed.
Follow-up and outcomes
- Scheduled visits with due windows and completion dates
- Patient-reported outcomes (ODI, VAS, EQ-5D, specialty instruments)
- Clinician-assessed outcomes and imaging findings
- Baseline versus latest change, computed automatically
Missed windows raise overdue flags and feed the follow-up compliance KPI.
Safety
- Adverse events with seriousness and device relatedness
- Device deficiencies and malfunctions
- Reportability decision, reporting date and regulator reference
- Link from a registry event to a complaint or CAPA in QualityOS
Reportable-but-unreported events are surfaced as an alert, not buried in a list.
Regulatory fit
How the evidence meets your obligations
Qevatrix provides the system and the evidence trail; the regulatory conclusions remain yours.
| Requirement | Framework | How EvidenceOS delivers it |
|---|---|---|
| PMCF plan and PMCF evaluation report | EU MDR Annex XIV Part B / MDCG 2020-7 and 2020-8 | The registry is the PMCF data source; the registry report exports the enrolment, follow-up, outcome and safety sections in the structure the evaluation report expects. |
| Post-market surveillance plan and PSUR input | EU MDR Article 83–86 | Registry safety events, revision rates and survivorship feed the PSUR trend sections and connect to PMS cases in QualityOS. |
| Clinical evaluation with sufficient clinical evidence | EU MDR Annex XIV Part A / MEDDEV 2.7-1 rev 4 logic | Real-world outcomes from the registry are appraised alongside literature so the clinical evaluation cites your own data set. |
| Post-market surveillance and complaint handling | 21 CFR 820 / FDA QMSR, 21 CFR 803 | Registry events can be escalated into complaints and MDR decision workflows with the reporting clock running. |
| Registry conduct and data quality | ISO 14155 principles, FDA RWE guidance | Defined protocol, source data verification, query management, monitoring records and a complete audit trail on every change. |
| Electronic records and signatures | 21 CFR Part 11, EU Annex 11 | Unique accounts, reason-for-change capture, immutable audit history and manifest e-signatures on controlled outputs. |
| Personal data protection | GDPR, HIPAA safeguards | De-identified capture by design, role-scoped access, PHI access logging, retention schedules and data-processing terms. |
Common questions
Before you commit
- How long before the first patient can be entered?
- Typically four to six weeks for a standard specialty registry — most of that is agreeing the data set and onboarding sites, not software work.
- Do participating sites have to pay?
- No. The site portal for coordinators and investigators is free; the registry holder subscribes.
- Who owns the data?
- The registry holder. Exports are controlled and de-identified by design, and sponsor or society sharing rules are set in your agreement.
- Can we migrate an existing registry?
- Yes — historical participants, procedures, implants and visits can be imported from spreadsheets or an existing database with field mapping and a preview before anything is written.
Start your registry on EvidenceOS
Open the guided demo to see the registry, KPIs and PMCF report with sample data, or ask for a quote scoped to your registries and sites.