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 · Available now
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 generally available. Self-service checkout is not enabled — every engagement starts with a demo and scoping call.
EvidenceOS · Available now
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 generally available and launches with the orthopedic and spinal implant specialty pack; additional specialties are configured with your team. Registry engagements start with a demo and scoping call rather than self-service checkout.
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.
DistributorOS · Available now
Qevatrix DistributorOS
Run inventory, surgical cases, manufacturers, physicians, sales, commissions, communications, education, analytics and AI automation from one platform.
Annual billing charges 10 months and gives you 12 — about 17% off.
Starter
$108/month
$1,290 billed annually · $129/month month-to-month
For independent distributors and small teams getting off spreadsheets.
- Up to 3 users
- 1 distributor organisation
- Up to 2 manufacturer partners
- Product catalog
- Implant and device inventory
- Lot, serial and expiration tracking
- Consignment inventory
- Loaner instrument tracking
- Basic case scheduling
- Hospital and account management
- Physician and contact CRM
- Basic scrub-form creation
- Mobile photo and document capture
- Basic AI assistant
- Basic reporting
- Email support
Growth
$270/month
$3,240 billed annually · $324/month month-to-month
Less than $11 a day.
For growing distributors that want to automate sales, cases, inventory, manufacturers and physician engagement.
- Everything in Starter
- Up to 10 users
- Unlimited manufacturer partners
- Automated catalog importing with intelligent field mapping
- Case-management workflows and territory management
- Surgeon CRM, sales pipeline, opportunities and quotes
- Commission tracking
- Trunk, consignment and loaner kit management
- Barcode, QR and phone-camera scanning
- Expiration, low-stock and par-level alerts with replenishment recommendations
- Automatic scrub-sheet creation and AI extraction from scanned sheets
- Automatic manufacturer routing and communication workflows
- AI-generated physician emails and follow-up suggestions
- Product and procedure education engine
- AI what-should-I-do-next guidance
- Sales, inventory and case analytics
- PDF and Excel exports, automated and emailed reports
Professional
$541/month
$6,490 billed annually · $649/month month-to-month
For established multi-line and multi-territory medical-device distributors.
- Everything in Growth
- Up to 25 users
- Multiple territories and warehouses
- Advanced commission rules by manufacturer, product, rep, territory, case and hospital
- Sales-rep performance analytics and forecasting
- AI demand forecasting and inventory optimisation
- Advanced replenishment automation
- Manufacturer portal access
- Automated physician campaigns, product launches and educational drips
- Margin and gross-profit analytics
- Contract and pricing management
- Custom workflows
- Accounting integrations and API access
- Advanced import and export
- Priority support
Enterprise
Starting at$1,299/month
configured to your organisation
For large distributors, multi-region organisations and complex operations.
- High or unlimited user allowances
- Multiple distributor and legal entities
- Regional organisations and multiple warehouses
- Manufacturer and distributor network management
- Custom, ERP, CRM and accounting integrations
- SSO and advanced security controls
- API access and custom AI workflows
- Dedicated onboarding and data migration assistance
- Custom dashboards and reporting
- Advanced audit controls and permissions
- Priority implementation, premium support and SLA options
No credit card required • No setup fee • Cancel anytime
Prices in USD, per distributorship (not per representative), excluding applicable taxes. Annual billing charges ten months and gives you twelve; month-to-month rates are shown with the billing toggle.
ReimbursementOS · Available now
Qevatrix ReimbursementOS
Coding and Medicare payment reference for device teams. Pricing is quoted per organization based on users and device categories.
Organization
Coding, reimbursement and market access teams
Quoted per organization
annual agreement
Named users, agreed at onboarding
AI change summaries included with fair-use protections
- Device code lookup across CPT, HCPCS, ICD-10-PCS, ICD-10-CM, MS-DRG and APC
- Medicare payment amounts by care setting with source and effective date
- Pass-through, NTAP and device-intensive flags, NCCI edits and MUE limits
- Daily monitoring of official CMS sources with watch-list alerts
- Saved lookups and estimates with notes
AI included with fair-use protections. Allowances are per tier and abuse controls apply; we contact you before any limit affects your work.
For reference only. Verify with official CMS sources and payer contracts before billing. Prices in USD, excluding applicable taxes.
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.
Bundles
One agreement for several applications
Applications share a tenant, an identity and an audit trail, so buying them together costs less than buying them separately.
Bundle pricing is loading. If it does not appear, please contact us for a quote.
Plan selector
Which Qevatrix plan do I need?
Answer three questions and we will point you at the smallest plan that covers your work.
1. What do you need to run?
2. Where are you today?
3. How many people will work in it?
Questions
Users, seats, annual billing and startup pricing
The answers below come straight from the live plan catalog, so they always match the prices above.
- How many users are included?
- Each plan states its included user allowance on its card. Read-only reviewers, auditors and approvers are generous by design, so you never pay to let someone check a record.
- What happens if we need more seats?
- Editing users are capped by plan; read-only and approval-only people are far more generous. If you go past the allowance you can add users to your current plan or move up a tier — we will always show you which is cheaper before you commit, and we never cut off access mid-term for going over.
- Is pricing per user or per company?
- Per application, per organisation — not per employee. One QualityOS subscription covers your whole company, including every site and legal entity you set up inside it. Only the named editing-user allowance is capped.
- How much does annual billing save?
- Annual billing is the recommended option and is invoiced once for the year. Plans priced per study or per registry are annual by nature.
- Do you offer startup pricing?
- Early-stage medical device companies can ask about startup pricing when they request a quote.
- Can we buy several applications together?
- Yes. Applications share one tenant, one identity and one audit trail, so buying them together costs meaningfully less than buying them separately. The Clinical Evidence Suite and Qevatrix Complete bundles are priced on the bundles page.
- Are there setup or implementation fees?
- No mandatory setup fee on self-serve plans. Guided migration of an existing quality system and validation support are quoted separately only when you want us to do the work for you.
- Can we try it before we buy?
- Yes. Self-serve plans start with a free trial in your own workspace with your own data — no card needed to begin. ClinicalOS, EvidenceOS and enterprise agreements start with a demo instead, because they are configured around your study or registry.
- What is included in every plan?
- The append-only audit trail, Part 11-ready electronic signatures, standard validation documentation, role-based access and AI with fair-use protections. Compliance features are never an upsell.
- How do we pay, and can we cancel?
- Card or invoice, in USD. Annual terms run for twelve months and renew only if you do not give 30 days' notice; month-to-month plans, where offered, end at the close of any billing month.
Still unsure? Ask us directly — we will tell you if a cheaper plan covers what you need.