RegulatoryOS
Available nowSubmissions, registrations and regulatory intelligence in one place.
RegulatoryOS manages the regulatory lifecycle of a device portfolio: classification, submission planning, dossier assembly, global registrations, change assessment and standards monitoring — with full traceability back to the quality record.
Built for: Regulatory affairs teams managing multi-market device portfolios
Sign in at qevatrix.com/auth?product=regulatoryos · address regulatoryos.qevatrix.com reserved
About this app
Plan, build and maintain device submissions and market registrations from the same records your quality system already controls.
RegulatoryOS manages the regulatory portfolio: submission planning and dossier assembly, market registrations and their renewal clocks, standards and regulatory intelligence, and the change assessments that decide whether a modification needs a new filing.
What you can do
- Plan submissions and assemble dossiers per market and device family
- Track registrations, licence numbers, authorized representatives and expiry dates
- Assess design and labelling changes for filing impact
- Monitor standards and regulatory updates affecting the portfolio
Problems it solves
- Registrations and renewals tracked in spreadsheets, with expiry surprises
- Dossiers rebuilt by hand for every market from the same underlying evidence
- Regulatory change impact that is assessed too late to plan for
Who it is for
- Regulatory affairs managers and specialists
- Submission and dossier authors
- Distributors and in-country representatives
- Quality leaders accountable for market access
Works with
- QualityOSQualityOS holds the controlled documents, design history and risk files that a submission cites; RegulatoryOS references them instead of copying them.Learn more
- DeviceOSDeviceOS bundles RegulatoryOS with QualityOS so both run against the same device record and audit trail.Learn more
- ClinicalOSPlanned integrationClinical investigation reports produced in ClinicalOS are intended to support clinical evaluation content in submissions.Learn more
One approved record can serve every market at once: change a controlled document in QualityOS and RegulatoryOS immediately shows which submissions and registrations are affected.
Capabilities
What RegulatoryOS does
Every module writes to the same controlled record set, so nothing has to be exported, re-keyed or reconciled.
Submission management
510(k), De Novo, PMA, IDE, MDR technical documentation and international dossiers with structured content plans, section ownership, deadlines and review cycles.
Global registrations
Registration and licence tracking by country, authorized representative, importer and distributor, with expiry alerts and renewal workflows.
Change assessment
Structured significant-change evaluation for design, labeling, materials, suppliers and manufacturing, producing a defensible rationale record for each decision.
Regulatory intelligence
Monitoring of standards, guidance and rule changes, routed to the product families and processes they actually affect, with owner assignment and impact records.
Labeling and UDI
Label content control, symbol libraries, translation status, UDI record management and database submission tracking.
Dossier assembly
Compile submission-ready packages directly from controlled documents and design records, with source traceability preserved on every attachment.
Regulatory foundation
Standards it is built against
- 21 CFR Part 807 / 814 / 812
- EU MDR 2017/745
- IMDRF Table of Contents
- ISO 13485
- MDSAP
- Health Canada, UKCA, TGA, PMDA pathways
Qevatrix Intelligence
Where AI helps — and where it stops
RegulatoryOS drafts submission sections, summarizes guidance changes and proposes change-assessment rationales. It never makes a final regulatory conclusion or files anything on its own.
FDA QMSR transition guide
What changes as the FDA moves from 21 CFR Part 820 to ISO 13485:2016 alignment, and a transition sequence that survives an audit.
Read the guidePricing
RegulatoryOS plans
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.
Already running QualityOS?
Buy both applications as DeviceOS for $2,995 per month billed annually — about 21% less than two Professional subscriptions.
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.
Compare
What is in each plan
| Capability | Essentials | Professional | Enterprise |
|---|---|---|---|
| Regulatory operations | |||
| Registration and licence tracking | Included | Included | Included |
| Change assessment | Included | Included | Included |
| Product and market records | Included | Included | Included |
| Submission management | Not included | Included | Included |
| Dossier assembly and exports | Not included | Included | Included |
| Labeling and UDI workflows | Not included | Included | Included |
| Regulatory intelligence | Alerts | Included | Advanced routing |
| Compliance foundation | |||
| Append-only audit trail | Included | Included | Included |
| Part 11-ready electronic signatures with captured meaning | Included | Included | Included |
| Standard validation documentation | Included | Included | Included |
| Authority and delegation controls | Standard | Standard | Granular |
| Scale and access | |||
| Power users | Up to 10 | Up to 25 | Unlimited |
| Markets and product families | Limited | Broad | Unlimited |
| SSO (SAML/OIDC) | Not included | SSO-ready | Included |
| API access | Not included | Not included | Included |
Value
The commercial case
Why this is cheaper than the spreadsheet
Professional is about $21,540 per year. A single missed registration renewal, an unassessed design change or a rebuilt dossier typically costs more than that in delayed revenue and consultant time.
- Registration expiries surfaced before they become market interruptions
- Change assessments with written rationale, ready for an auditor
- Dossier assembly from controlled records rather than a shared drive
- Guidance changes monitored continuously instead of quarterly
Questions
RegulatoryOS pricing FAQ
- What counts as a market or product family?
- A market is a jurisdiction you hold or seek authorisation in; a product family groups models sharing a technical file. Essentials suits a focused portfolio, Professional a broad one, and Enterprise removes the limits.
- 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.