EvidenceOS
Early accessReal-world evidence and device registries, starting with orthopedic and spinal implants.
EvidenceOS is a universal registry engine for medical device real-world evidence. It launches as EvidenceOS — Orthopedic & Spinal Implants, with a configuration-driven architecture built for unlimited future specialties.
Built for: Manufacturers, societies and consortia building device registries
Sign in at qevatrix.com/auth?product=evidenceos · address evidenceos.qevatrix.com reserved
About this app
Build and run device registries and real-world evidence programmes on de-identified data you can defend.
EvidenceOS consolidates de-identified clinical outcomes into registry operations: cohort and participant registers, outcome instruments, follow-up windows, signed registry records and the analysis views that turn them into real-world evidence — starting with orthopedic and spinal implants.
What you can do
- Receive de-identified cohorts and maintain registry participant records
- Run outcome instruments and follow-up schedules across the registry
- Sign and lock registry records with electronic signatures
- Analyse outcomes for real-world evidence and post-market reporting
Problems it solves
- Registry data collected in silos with no consistent outcome instruments
- Real-world evidence that cannot show where each data point came from
- Manual follow-up tracking and missed collection windows
Who it is for
- Registry programme managers
- Clinical and biostatistics analysts
- Manufacturers building post-market evidence
- Professional societies and multi-centre consortia
Works with
- ClinicalOSClinicalOS is the upstream source: cohorts arrive de-identified through an audited transfer, never as raw patient records.Learn more
- StudyOSStudyOS oversight covers the study execution that produces the data EvidenceOS consolidates.Learn more
- QualityOSPlanned integrationRegistry outcomes are intended to feed post-market surveillance and risk files in QualityOS.Learn more
Evidence keeps its provenance: an outcome in EvidenceOS traces back through a recorded de-identification transfer to the ClinicalOS import that produced it.
Capabilities
What EvidenceOS does
Every module writes to the same controlled record set, so nothing has to be exported, re-keyed or reconciled.
Universal registry engine
Sponsors, sites, investigators, subjects, procedures, diagnoses, devices, UDI, lots, implants, anatomical locations, outcomes, adverse events, device deficiencies, revisions and reoperations as first-class configurable entities.
Orthopedic and spinal implant specialty pack
Cervical, thoracic, lumbar, SI and facet procedures with treated levels, surgical approach, interbody and fixation devices, decompression, fusion, biologics, previous surgery and concomitant procedures.
Outcome instruments
ODI, NDI, VAS/NRS, quality-of-life measures and satisfaction, with change-from-baseline analysis and completeness tracking per timepoint.
Radiographic and device outcomes
Fusion assessment, migration, subsidence, loosening, implant fracture, revision and reoperation captured as structured, analyzable endpoints.
Future specialty packs
Orthopedics, joint replacement, trauma, SI fusion, interventional pain, neuromodulation, cardiovascular, robotics, biologics and wound care are configuration, not new software.
Evidence outputs
De-identified, controlled exports and validated analysis outputs suitable for post-market surveillance, PMCF and regulatory evidence packages.
Regulatory foundation
Standards it is built against
- FDA medical device RWE guidance
- 21 CFR Part 11
- ISO 14155 where applicable
- HIPAA-aligned de-identification
- EU MDR PMCF
Qevatrix Intelligence
Where AI helps — and where it stops
EvidenceOS proposes registry configurations, drafts data dictionaries and surfaces signal patterns for review. Safety and performance conclusions remain human decisions with documented rationale.
Modules
EvidenceOS module by module
Every module has its own page with features, plan availability and pricing.
Universal Registry Engine
One engine for every registry — configuration, not custom software.
Orthopedic & Spinal Implant Specialty Pack
The launch specialty: levels, approach, implants, biologics, fusion and revision out of the box.
Outcome Instruments
ODI, NDI, VAS/NRS and quality-of-life measures with change-from-baseline analysis.
Analytics & Cohort Comparison
A clinical analytics engine over live registry data — not placeholder dashboards.
PMCF & PMS Evidence Reports
Regulatory evidence outputs generated from the registry, not rebuilt in Word.
Client Portal
Your registry clients sign in and see their own KPIs, reports and outstanding data.
Outstanding Data Reminders & Escalation
Automatic chasing of missing visits, outcomes and documents — with levels 1–5 escalation.
Pricing
EvidenceOS plans
A universal registry engine for real-world evidence, priced per registry — built for PMS and PMCF programmes that have to run for years.
Registry
A single specialty registry or PMCF programme
$2,495/month
billed annually, per registry · $29,940 per year
Registry team users included · up to 30 participating sites
AI registry configuration support, fair use
- Universal registry engine
- One specialty pack
- Standard outcome instruments
- Controlled de-identified exports
- Part 11-ready signatures and audit trail
Evidence Program
Manufacturers running ongoing PMS, PMCF and RWE work
$4,995/month
billed annually · $59,940 per year
Up to 3 registries or specialty programmes · higher site capacity
Higher AI allowance across programmes, fair use
- Everything in Registry, for up to 3 registries or specialty programmes
- Advanced analytics and cohort comparison
- PMCF and PMS evidence outputs
- Custom outcome instruments within reasonable limits
- Expanded site capacity
Consortium / Enterprise
Societies, consortia and multi-specialty programmes
Get A Quote
annual agreement
Custom registry, site and sponsor scale
Custom AI allowances and controls
- Multiple registries and specialties
- Sponsor and society permission models
- Custom analytics and data-sharing agreements
- API access
- Dedicated evidence support
- Custom hosting and security requirements
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Feeds your quality system
EvidenceOS outputs flow into PMS, PMCF and risk workflows in QualityOS and RegulatoryOS — one identity, one audit trail, no exports.
Prices in USD, excluding applicable taxes. EvidenceOS is in early access and launches with the orthopedic and spinal implant specialty pack; additional specialties are configured with early-access partners. Self-service checkout is not enabled.
Compare
What is in each plan
| Capability | Registry | Evidence Program | Consortium / Enterprise |
|---|---|---|---|
| Registry capability | |||
| Universal registry engine | Included | Included | Included |
| Specialty packs | 1 | Up to 3 | Multiple |
| Standard outcome instruments | Included | Included | Included |
| Custom outcome instruments | Not included | Within limits | Custom |
| Advanced analytics and cohort comparison | Not included | Included | Custom |
| PMCF and PMS evidence outputs | Not included | Included | Included |
| Scale and governance | |||
| Participating sites | Up to 30 | Expanded | Custom |
| Controlled de-identified exports | Included | Included | Included |
| Sponsor / society permission models | Not included | Not included | Included |
| API access | Not included | Not included | Included |
| Custom hosting and security | Not included | Not included | Included |
Value
The commercial case
Registries usually cost more to build than to run
Bespoke registry builds are commonly six-figure development projects before the first patient is entered. Registry is $29,940 per year on a configuration-driven engine, so the specialty pack is configuration rather than a software project.
- Configuration-driven — no custom build per specialty
- One evidence trail across sites, sponsors and years
- PMCF and PMS outputs generated from the registry, not rebuilt in Word
- Per-registry pricing that matches how programmes are funded
Questions
EvidenceOS pricing FAQ
- What is a specialty pack?
- A configured set of entities, outcome instruments and data dictionary for one clinical specialty — orthopedic and spinal implants are available first, and additional specialties are configuration rather than new software.
- Who owns the registry data?
- The registry holder. Exports are controlled and de-identified by design, and data-sharing rules for sponsors and societies are defined in your agreement.
- Can we cancel?
- Subscriptions run for the committed term. Annual plans do not auto-escalate mid-term, and you can choose not to renew with 30 days' notice before the renewal date. Month-to-month plans, where offered, can be cancelled at the end of any billing month.
- How much does annual billing save?
- Annual commitment is the recommended option and is priced roughly 15-20% below the equivalent month-to-month rate. The exact saving for each plan is shown on its card when you switch the billing toggle.
- Is onboarding included?
- Standard onboarding — tenant setup, configuration walkthrough, administrator training and the standard validation documentation — is included on self-service tiers. Assisted implementation, data migration and executed validation are optional paid services, quoted before you buy. Enterprise implementation is scoped in your agreement.
- Are there mandatory implementation fees?
- No. Nothing is invoiced that is not on your order form. If your deployment needs assisted implementation or executed IQ/OQ, we quote it up front as an optional service rather than adding it later.
- How are users counted?
- Pricing is based on edit and power users — people who create, review, approve or sign records. Read-only, training-only and basic users are generous by design, because a quality or regulatory system only works when everyone can see it.
- Is AI included?
- AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
- Do we pay for updates?
- No. Product updates, new capability within your tier and regulatory content updates are part of the subscription. Version history and validation impact notes are published with each release.
- What support is included?
- All plans include email support from people who have worked in regulated environments. Professional and above include prioritised response targets; Enterprise agreements can define named contacts and response commitments.
- What does Enterprise add?
- Multi-site and unlimited scale, SAML/OIDC and SCIM-ready provisioning, dedicated validation support, custom retention and data residency, API and integration work, and priority onboarding. Enterprise is always a quoted annual agreement.
- Can we upgrade later?
- Yes. Applications share one tenant and one identity, so moving up a tier or activating another Qevatrix application makes your existing records available immediately — there is no migration and no re-keying. Upgrades are pro-rated.
- Can we get our data out?
- Always. Records, revisions, signature manifests and the audit trail export to open formats (CSV and PDF packages), and Enterprise agreements can add scheduled or API-based extraction.