QualityOS
Available nowAn AI-native eQMS that people actually want to use.
QualityOS runs the full quality system for a medical device company — documents, training, CAPA, complaints, nonconformances, audits, suppliers and management review — with Part 11 electronic signatures and an immutable audit trail underneath every record.
Built for: Quality and RA teams at device manufacturers, from startup to enterprise
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About this app
Operate a complete, inspection-ready quality management system with Part 11 signatures and an immutable audit trail under every record.
QualityOS runs the full quality system for a medical device company: document control, training, CAPA, nonconformance, complaints, risk management, design controls, post-market surveillance, suppliers, equipment calibration, audits and management review — all with electronic signatures and an append-only audit trail.
What you can do
- Control SOPs and forms with revisions, review cycles, change orders and effective dates
- Open, investigate, action and verify CAPAs, nonconformances and complaints
- Maintain ISO 14971 risk files, design controls (DHF/DMR) and post-market surveillance
- Assign role-based training, run audit checklists and hold management reviews
- Track equipment calibration, suppliers, standards editions and quality KPIs
Problems it solves
- Quality evidence scattered across shared drives, spreadsheets and email
- Manual, error-prone reference numbering and revision control
- Audits and inspections that require weeks of evidence assembly
Who it is for
- Quality assurance and quality system managers
- CAPA owners and process engineers
- Internal auditors and management representatives
- Training coordinators and document controllers
Works with
- RegulatoryOSRegulatoryOS reads approved quality records — design, risk and post-market evidence — as the source material for submissions and registrations.Learn more
- DeviceOSDeviceOS is the bundle that activates QualityOS and RegulatoryOS side by side in one tenant.Learn more
- EvidenceOSPlanned integrationEvidenceOS registry outcomes are intended to feed post-market surveillance and risk review inside QualityOS.Learn more
Quality events, risk files and post-market findings stay in one controlled record set, so regulatory work starts from evidence that has already been reviewed, signed and time-stamped.
Capabilities
What QualityOS does
Every module writes to the same controlled record set, so nothing has to be exported, re-keyed or reconciled.
Document control
Controlled SOPs, work instructions, forms and templates with revision control, review cycles, effective dates, periodic review and obsolete-copy handling. Approved records are never silently modified.
CAPA
Structured intake, containment, investigation, root cause, action planning, effectiveness checks and closure — with the evidence chain preserved and escalation rules configurable per site.
Complaints and vigilance
Complaint intake, triage, medical device reporting decision support, investigation linkage to CAPA and device history, plus reportability decision records that only a qualified person can finalize.
Nonconformance
NC intake, disposition, material review board workflow, rework and scrap accounting, plus trending that surfaces recurring defect patterns before they become systemic.
Training and competency
Role-based curricula, automatic assignment on document release, read-and-understood attestations, competency records and audit-ready training matrices.
Internal and external audits
Audit scheduling, checklists, findings, responses, corrective actions and inspection-ready evidence packages generated on demand.
Supplier quality
Approved supplier list, qualification, risk classification, performance scorecards, supplier corrective action requests and re-evaluation scheduling.
Management review
Automatic assembly of QMS inputs — audits, feedback, CAPA status, process performance, supplier performance — into a structured review record with actions tracked to closure.
Regulatory foundation
Standards it is built against
- 21 CFR Part 820 / QMSR
- 21 CFR Part 11
- ISO 13485:2016
- ISO 14971:2019
- EU MDR Annex IX
- MDSAP
Qevatrix Intelligence
Where AI helps — and where it stops
QualityOS drafts investigations, summarizes complaint history, proposes root-cause hypotheses and pre-fills management review inputs. It never approves a CAPA, closes a complaint, determines final reportability or signs a record.
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
QualityOS plans
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.
Add RegulatoryOS
QualityOS customers who also manage registrations and submissions buy both as the DeviceOS bundle and save about 21% against two Professional subscriptions.
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.
Compare
What is in each plan
| Capability | Essentials | Professional | Enterprise |
|---|---|---|---|
| Quality modules | |||
| Document control and change orders | Included | Included | Included |
| Training and retraining | Included | Included | Included |
| CAPA (8D lifecycle) | Included | Included | Included |
| Nonconformance | Included | Included | Included |
| Complaints and reportability review | Not included | Included | Included |
| Audits | Not included | Included | Included |
| Supplier quality | Not included | Included | Included |
| Management review | Not included | Included | Included |
| Trending and analytics | Core | Advanced | Advanced |
| Standards monitoring (ISO/ASTM/ANSI) | Included | Included | Included |
| 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 |
| AI compliance review on document import | Included | Included | Included |
| Executed IQ/OQ support | Optional service | Optional service | Included |
| Platform and access | |||
| Edit/power users | Up to 15 | Up to 50 | Unlimited |
| Read, training and basic users | Unlimited | Unlimited | Unlimited |
| Configurable approval matrices | Not included | Included | Included |
| SSO (SAML/OIDC) | Not included | SSO-ready | Included |
| SCIM provisioning | Not included | Not included | SCIM-ready |
| API access | Not included | Not included | Included |
| Data residency and custom retention | Not included | Not included | Included |
Value
The commercial case
What Professional replaces
Professional is about $23,940 per year. Typical eQMS subscriptions in this market are five-figure annual investments before services, and enterprise systems reach six figures — with published entry points around $26,000 per year plus implementation and validation fees.
- One subscription instead of a document system, a training tracker and spreadsheets for CAPA, complaints and suppliers
- Standard validation documentation included rather than quoted per deployment
- Audit preparation from live records instead of a two-week evidence hunt
- No per-employee charge for people who only need to read or train
Questions
QualityOS pricing FAQ
- Do read-only and training users cost extra?
- No. Edit and power users are what you pay for. Everyone else in the company can read effective documents and complete training without a paid seat.
- 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.