DeviceOS
Available nowThe medical device operating system.
DeviceOS bundles QualityOS and RegulatoryOS into one subscription for device manufacturers who want quality and regulatory operations running on a single record set, a single identity and a single audit trail.
Built for: Device manufacturers consolidating quality and regulatory operations
Sign in at qevatrix.com/auth?product=deviceos · address deviceos.qevatrix.com reserved
About this app
Run quality and regulatory operations for a medical device company on one record set, one identity and one audit trail.
DeviceOS is the combined subscription for device manufacturers: it activates QualityOS and RegulatoryOS inside a single tenant so design controls, risk, CAPA, submissions and market registrations all read and write the same underlying records.
What you can do
- Maintain one device record — families, models, UDI-DI, classifications and registrations
- Run design controls, risk files and the traceability matrix against live quality data
- Track submissions, registrations and expiries next to CAPA and complaint activity
- Review cross-module KPIs for audit readiness on a single dashboard
Problems it solves
- Quality and regulatory teams maintaining two disconnected systems of record
- Re-keying device, risk and design data into submission dossiers
- Audit findings caused by evidence that cannot be traced end to end
Who it is for
- Quality managers and QA/RA leads
- Regulatory affairs specialists
- Design and development engineers
- Operations and executive management
Works with
- QualityOSQualityOS supplies the controlled quality record — documents, CAPA, complaints, audits and training — that DeviceOS exposes in one console.Learn more
- RegulatoryOSRegulatoryOS turns those quality records into submissions and market registrations without re-keying or exporting them.Learn more
Because both modules run in the same tenant, an approved document, a closed CAPA or a signed risk file is immediately usable as submission evidence — nothing is exported, re-keyed or reconciled between systems.
Capabilities
What DeviceOS does
Every module writes to the same controlled record set, so nothing has to be exported, re-keyed or reconciled.
Unified device record
Product families, models, UDI-DI, catalog numbers, classifications and market registrations resolve to one device record shared by every module.
Design controls and risk
User needs, design inputs and outputs, verification, validation, design reviews and the traceability matrix, linked to ISO 14971 risk files.
Post-market feedback loop
Complaints, vigilance signals and clinical evidence feed risk files and periodic reports without exports or manual reconciliation.
Cross-module analytics
Quality and regulatory KPIs on one dashboard: overdue CAPAs, submission timelines, registration expiries, audit readiness.
Regulatory foundation
Standards it is built against
- 21 CFR Part 820 / QMSR
- 21 CFR Part 11
- ISO 13485
- ISO 14971
- EU MDR 2017/745
Qevatrix Intelligence
Where AI helps — and where it stops
Qevatrix Intelligence works across both modules: it drafts, cross-references and flags inconsistencies between quality records and regulatory dossiers. Every output is a recommendation until a qualified person approves it.
Pricing
DeviceOS plans
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.
Clinical evidence too?
Manufacturers running clinical investigations or post-market registries pair DeviceOS with ClinicalOS and EvidenceOS on the same identity and audit trail.
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.
Compare
What is in each plan
| Capability | DeviceOS Professional Bundle | DeviceOS Enterprise |
|---|---|---|
| Bundle scope | ||
| QualityOS Professional modules | Included | Included |
| RegulatoryOS Professional modules | Included | Included |
| Unified device record across modules | Included | Included |
| Cross-module analytics | Included | Included |
| Compliance foundation | ||
| Append-only audit trail | Included | Included |
| Part 11-ready electronic signatures | Included | Included |
| Validation package | Included | Custom |
| Executed IQ/OQ support | Optional service | Included |
| Scale and access | ||
| Users | Up to 50 | Unlimited |
| Sites | Single organisation | Multi-site / global |
| SSO and SCIM | SSO-ready | Included |
| API and integrations | Not included | Included |
| Data residency and retention | Standard | Custom |
Value
The commercial case
Bundle savings, stated plainly
QualityOS Professional ($1,995) plus RegulatoryOS Professional ($1,795) is $3,790 per month billed annually. DeviceOS is $2,995 — a saving of $795 per month, about 21%, or $9,540 a year.
- One subscription, one tenant, one identity, one audit trail
- Design changes assessed against quality records without re-keying
- Post-market signals feed risk files and periodic reports directly
- Instant module activation — no migration project between the two
Questions
DeviceOS pricing FAQ
- How is the 21% saving calculated?
- QualityOS Professional at $1,995/month plus RegulatoryOS Professional at $1,795/month is $3,790/month billed annually. The DeviceOS bundle is $2,995/month billed annually, which is 20.97% lower.
- Can we start with one application and add the other?
- Yes, and it is the common path. When you add the second application your existing records are immediately available to it, and your subscription moves to bundle pricing at that point.
- 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.