Pricing — for medical device professionals and manufacturers
Premium regulatory and quality software without legacy enterprise pricing.
Priced per application in USD, per organisation — not per employee. Annual billing is the recommended option and runs about 15-20% below month-to-month. Every plan includes the append-only audit trail, Part 11-ready electronic signatures, standard validation documentation and AI with fair-use protections.
DeviceOS · Available now
Qevatrix DeviceOS
QualityOS and RegulatoryOS in one subscription, one tenant and one audit trail — priced about 21% below buying both Professional plans separately.
DeviceOS Professional Bundle
Device manufacturers consolidating quality and regulatory operations
$2,995/month
billed annually · $35,940 per year
Up to 50 users across both applications
Combined higher AI allowance, fair use
- Full QualityOS Professional scope
- Full RegulatoryOS Professional scope
- Unified tenant, identity and audit trail
- Cross-module analytics across quality and regulatory KPIs
- Validation package included
- Priority implementation
DeviceOS Enterprise
Multi-site and global device organisations
Get A Quote
annual agreement
Unlimited users and sites
Custom AI allowances and controls
- Everything in the Professional Bundle
- SSO, SCIM-ready provisioning and API access
- Custom validation and integration work
- Custom data retention and residency
- Dedicated customer success
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Prices in USD, per organisation, excluding applicable taxes. Bundle savings are calculated against the current published QualityOS and RegulatoryOS Professional annual-billed rates and are stated without discount theatre.
QualityOS · Available now
Qevatrix QualityOS
A complete, Part 11-ready eQMS for medical device teams — priced so a lean startup and a 50-person quality organisation can both buy it without a six-figure procurement cycle.
Essentials
Startups and lean device teams building their first controlled QMS
$995/month
billed annually · $11,940 per year
Up to 15 edit/power users · unlimited read, training and basic users
Core AI drafting and assistance, fair use
- Document Control with revisions and change orders
- Training records and retraining tasks
- CAPA with 8D lifecycle
- Nonconformance management
- Part 11-ready electronic signatures and append-only audit trail
- Standard validation documentation
- Standard onboarding included
Professional
Commercial-stage manufacturers running a full quality system
$1,995/month
billed annually · $23,940 per year
Up to 50 edit/power users · unlimited read, training and basic users
Higher AI allowance, fair use
- Everything in Essentials
- Customer complaints with reportability review
- Internal and external audits
- Supplier quality management
- Management review inputs and outputs
- Advanced analytics and trending
- Configurable approval matrices
- SSO readiness
Enterprise
Multi-site and global quality organisations
Get A Quote
annual agreement
Unlimited users and sites
Custom AI allowances and controls
- Everything in Professional
- SAML/OIDC and SCIM-ready provisioning
- Dedicated validation and IQ/OQ support
- Custom retention and data residency
- API and integration support
- Priority onboarding and support
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Prices in USD, per organisation (not per user), excluding applicable taxes. Annual billing is the recommended option; month-to-month rates are shown with the billing toggle. Nothing on this page is a claim of guaranteed compliance or guaranteed return — Qevatrix provides the system and the evidence trail; regulatory conclusions remain yours.
RegulatoryOS · Available now
Qevatrix RegulatoryOS
Registrations, change assessment and submissions on one controlled record set — priced for the regulatory team that is currently doing this in spreadsheets.
Essentials
Teams tracking registrations across a focused set of markets
$895/month
billed annually · $10,740 per year
Up to 10 power users · unlimited read-only users
Core AI regulatory assistance, fair use
- Registration tracking with expiry and renewal alerts
- Change assessment records and rationale
- Product and market records
- Limited markets and product families
- Part 11-ready signatures and audit trail
- Standard onboarding included
Professional
Regulatory groups running submissions across multiple regions
$1,795/month
billed annually · $21,540 per year
Up to 25 power users · unlimited read-only users
Higher AI allowance, fair use
- Everything in Essentials
- Submission management and dossier assembly
- Regulatory intelligence and guidance change monitoring
- Labeling and UDI workflows
- Broader markets and product families
- Advanced reporting and exports
Enterprise
Global regulatory organisations with many product families
Get A Quote
annual agreement
Unlimited power users, markets and product families
Custom AI allowances and controls
- Everything in Professional
- Advanced regulatory intelligence routing
- Granular authority and delegation controls
- SSO (SAML/OIDC) and provisioning
- API and integration support
- Dedicated onboarding and support
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Prices in USD, per organisation, excluding applicable taxes. Annual billing is the recommended option. Regulatory intelligence is decision support, not regulatory advice; conclusions and filings remain with your qualified people.
ClinicalOS · Early access — engagements start with a demo
Qevatrix ClinicalOS
Protocol to clinical study report on one platform, priced per active study — so a first-in-human investigation does not need an enterprise clinical suite.
Single Study
Sponsors running one active clinical investigation
$2,750/month
billed annually, per active study · $33,000 per year
Study team users included · up to 20 sites
Core AI drafting for protocol, SAP and narratives, fair use
- EDC with edit checks and query management
- CTMS for sites, visits and monitoring
- eTMF with expected-document structure
- Protocol Builder and SAP Builder
- Validated, reproducible analysis foundation
- Part 11-ready signatures and audit trail
Clinical Program
Teams running several studies in parallel
From$5,500/month
billed annually · $66,000 per year
Up to 3 active studies · larger site capacity
Higher AI allowance across studies, fair use
- Everything in Single Study, for up to 3 active studies
- eConsent and ePRO
- Cross-study dashboards and enrolment tracking
- Dedicated study configuration support
- Programme-level document and training reuse
Enterprise
Sponsors with an ongoing clinical portfolio
Get A Quote
annual agreement
Custom study and site scale
Custom AI allowances and controls
- Unlimited or custom study portfolio
- Enterprise security and SSO
- Validation services and reproducibility evidence
- Integrations with safety, labs and imaging vendors
- Dedicated support
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Prices in USD, excluding applicable taxes. ClinicalOS is in early access: eConsent and ePRO are being rolled out with early-access sponsors and are not advertised as generally available. Self-service checkout is not enabled — every engagement starts with a demo and scoping call.
EvidenceOS · Early access — engagements start with a demo
Qevatrix EvidenceOS
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.
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.
StudyOS · Available now
Qevatrix StudyOS
Run your clinical study with a smaller team. AI-powered clinical study management built for medical-device sponsors, CROs and investigation sites — priced per active study, never per user.
StudyOS Launch
Pilot, feasibility and small investigator-led studies, small registries, PMCF studies and early-stage device companies
$833/month
billed annually, per active study · $9,995 per year
1 active study · up to 3 investigation sites · up to 150 subjects
Unlimited sponsor, investigator, coordinator, CRA and site users. AI included — no separate AI subscription.
- AI Study Assistant
- Study timeline and milestone management
- Site onboarding
- Study document tracking
- Audit trails
- Basic automated reminders
- Investigation Site Portal
- Basic query and issue management
- Basic AI study summaries
- Personnel and coordinator handoff continuity
- Optional ClinicalOS integration
- Optional EvidenceOS integration
StudyOS Professional
Multi-site medical-device studies, post-market studies, prospective and retrospective programmes, and FDA evidence-generation work
$2,083/month
billed annually, per active study · $24,995 per year
1 active study · up to 20 investigation sites · up to 1,000 subjects
Unlimited sponsor, investigator, coordinator, CRA and site users. AI included throughout, fair use.
- Everything in Launch, plus:
- Advanced study timeline and milestone management
- Site onboarding workflows
- Study document management
- Comprehensive audit trails
- Advanced automated reminders
- Automated missing-data follow-up
- Automated missing CT, imaging and document follow-up
- Query and issue management with monitoring workflows
- AI-generated study summaries
- AI site-performance monitoring
- Standard integrations and API access
- Dedicated customer success support
- ClinicalOS and EvidenceOS integration
StudyOS Advanced
Large multi-site studies, complex or higher-risk clinical programmes and sponsors managing larger subject populations
$2,916/month
billed annually, per active study · $34,995 per year
1 active study · up to 50 investigation sites · up to 5,000 subjects
Unlimited users of every role. Advanced AI study operations included.
- Everything in Professional, plus:
- Advanced AI study operations
- Advanced automated site follow-up
- Risk-based monitoring
- Advanced monitoring workflows
- Custom study workflows
- Advanced API and integration capability
- Single Sign-On
- Advanced role management
- Advanced dashboards and custom alerts
- Custom sponsor workflows
- Enhanced administrative controls
- Priority customer support
StudyOS Enterprise
CROs, large sponsors, multi-study organisations and manufacturers with ongoing clinical programmes
Custom pricing
annual agreement
Multiple active studies · portfolio-level scale · unlimited users
Multi-study AI intelligence with custom controls. Starting at approximately $69,000 per year.
- Multiple active studies
- Portfolio-level dashboards and cross-study analytics
- Enterprise user management and advanced permissions
- SSO and API integrations
- Custom workflows and enterprise security controls
- Dedicated onboarding, customer success manager and custom training
- Multi-study AI intelligence
- ClinicalOS and EvidenceOS integration
- Investigation Site Portal
- Priority support and custom service-level options
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Prices in USD per active study, excluding applicable taxes. Annual prepayment is the recommended option and saves roughly 16-17% against month-to-month. Completed studies can move to a reduced-rate archive. Enterprise agreements are quoted on active studies, sites, subjects, integrations and services.
TrademarkOS · Available now
Qevatrix TrademarkOS
Trademark clearance, filing and monitoring for the brands behind your products. TrademarkOS runs as its own application with its own published pricing.
Trademark Launch
One-off filing, no subscription
$39
annual agreement
one-time + USPTO fees — no subscription required
AI search and drafting included, fair use
- Comprehensive AI trademark clearance search
- Conflict Score™ with likelihood-of-confusion analysis
- Nice Classification and AI goods/services drafting
- Application preparation and filing readiness review
- Guided USPTO filing workflow and document storage
- 12 months of USPTO status monitoring and Office Action alerts
Free
Founders validating a name
$0
annual agreement
no credit card required
AI search and drafting included, fair use
- 10 Quick AI trademark searches per month
- Word mark and logo/image search where available
- Basic similarity analysis and Conflict Score™
- Save 1 proposed trademark
- Track 1 trademark with basic USPTO monitoring
Founder
Ongoing portfolio management
$190
annual agreement
per year (save 2 months) + applicable taxes
AI search and drafting included, fair use
- Unlimited Quick AI searches
- 10 Comprehensive AI analyses per month
- Up to 3 active trademarks
- Automatic USPTO/TSDR monitoring and deadline tracking
- AI Office Action explanation
- 1 guided application preparation per year
Pro
Ongoing portfolio management
$490
annual agreement
per year (save 2 months) + applicable taxes
AI search and drafting included, fair use
- Everything in Founder
- Up to 15 active trademarks and 3 users
- 50 Comprehensive AI analyses per month
- Office Action strategy analysis and response drafting
- Client/project workspaces and white-label PDF reports
- 3 guided application preparations and 1 simple Office Action draft per year
Business
Ongoing portfolio management
$990
annual agreement
per year (save 2 months) + applicable taxes
AI search and drafting included, fair use
- Everything in Pro
- Up to 75 active trademarks and 10 users
- 250 Comprehensive AI analyses per month
- Client portals, role-based permissions and bulk import
- Portfolio risk analytics and executive dashboard
- 10 guided application preparations, 5 simple and 2 advanced Office Action drafts per year
Enterprise
Ongoing portfolio management
From $2,490
annual agreement
per year — custom quote
AI search and drafting included, fair use
- 250 trademarks included, tiers to 500, 1,000 and 2,500+
- Up to 25 users, expandable
- Advanced client and workspace management
- API access and SSO when available
- Custom security controls and data retention
- Dedicated onboarding and priority support
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
Prices in USD. Subscriptions cover software access and AI usage. Premium transaction services are purchased separately (Comprehensive AI Clearance Search $29, Guided Application Preparation $49, Additional Class $25, Simple Office Action Draft $49, Advanced Office Action Draft from $129, Statement of Use / Maintenance $49, Additional Trademark Monitoring from $3/month). USPTO government fees are set by and paid directly to the USPTO — currently from $350 per class — and are always itemized separately from Qevatrix fees.
Portfolio
One agreement for the whole stack
Applications share a tenant, an identity and an audit trail, so adding one is activation rather than migration.
Qevatrix Complete
In developmentMedDevice AI OS — the whole portfolio on one tenant
Quality, regulatory, clinical and real-world evidence operations on one identity and one audit trail, with a single agreement and a single implementation. Enterprise scope is scoped per organisation; no public price is published yet.
- QualityOS and RegulatoryOS (DeviceOS scope)
- ClinicalOS for clinical investigations
- EvidenceOS for registries, PMS and PMCF
- Unified SSO, provisioning, retention and residency controls
- Dedicated implementation, validation support and customer success
Questions
Before you ask
- 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.