One identity. Every application.
Everything you need for quality, regulatory, clinical and evidence operations — for medical device professionals and manufacturers.
Qevatrix is an AI-native ecosystem for quality, regulatory, clinical and evidence operations. Seven applications, one record set, one audit trail — engineered so a single platform carries your company from design control to post-market surveillance, and keeps you compliant with US and international standards along the way.
- DeviceOSThe medical device operating system.
- QualityOSAn AI-native eQMS that people actually want to use.
- RegulatoryOSSubmissions, registrations and regulatory intelligence in one place.
- ClinicalOSProtocol to clinical study report, on one platform.
- EvidenceOSReal-world evidence and device registries, starting with orthopedic and spinal implants.
- StudyOSRun your clinical study with a smaller team.
- TrademarkOSTrademark intelligence for regulated brands.
- 7
- Applications
- 1
- Shared identity
- Part 11
- Signature-ready
- ISO 13485
- Aligned
The ecosystem
Seven applications that share one spine
Each application solves a specific job. Together they remove the exports, re-keying and reconciliation that make regulated work slow.
DeviceOS
The medical device operating system.
Run quality and regulatory operations for a medical device company on one record set, one identity and one audit trail.
Primary uses: 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.
For: Quality managers and QA/RA leads, Regulatory affairs specialists, Design and development engineers
deviceos.qevatrix.comQualityOS
An AI-native eQMS that people actually want to use.
Operate a complete, inspection-ready quality management system with Part 11 signatures and an immutable audit trail under every record.
Primary uses: 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.
For: Quality assurance and quality system managers, CAPA owners and process engineers, Internal auditors and management representatives
qualityos.qevatrix.comRegulatoryOS
Submissions, registrations and regulatory intelligence in one place.
Plan, build and maintain device submissions and market registrations from the same records your quality system already controls.
Primary uses: 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.
For: Regulatory affairs managers and specialists, Submission and dossier authors, Distributors and in-country representatives
regulatoryos.qevatrix.comClinicalOS
Protocol to clinical study report, on one platform.
Take a device investigation from protocol to clinical study report while keeping patient data protected and audit-ready.
Primary uses: Import patient data sheets with guided field mapping and ambiguity resolution; Validate outcome measures and resolve recognition errors before committing data; Invite investigational sites into the free site portal and manage coordinators.
For: Clinical operations and study managers, Data managers and clinical data entry staff, Investigational site coordinators
clinicalos.qevatrix.comEvidenceOS
Real-world evidence and device registries, starting with orthopedic and spinal implants.
Build and run device registries and real-world evidence programmes on de-identified data you can defend.
Primary uses: Receive de-identified cohorts and maintain registry participant records; Run outcome instruments and follow-up schedules across the registry; Sign and lock registry records with electronic signatures.
For: Registry programme managers, Clinical and biostatistics analysts, Manufacturers building post-market evidence
evidenceos.qevatrix.comStudyOS
Run your clinical study with a smaller team.
Give sponsors and CROs oversight of study execution across sites and portfolios without touching identifiable patient data.
Primary uses: Review site data oversight across the studies in the organisation; Monitor data completeness and follow-up status by site; Coordinate sponsor and CRO review of study execution.
For: Contract research organizations, Sponsor clinical oversight and monitoring teams, Study and project managers
studyos.qevatrix.comTrademarkOS
Trademark intelligence for regulated brands.
Watch, clear and defend brand assets for regulated companies where naming decisions carry regulatory weight.
Primary uses: Research and clear candidate product and brand names; Track the trademark portfolio and its renewal deadlines; Monitor for conflicting filings and brand risk.
For: Brand and marketing leaders, In-house legal and IP counsel, Regulatory affairs teams reviewing labelling names
One platform, whole company
Run the entire company on Qevatrix
From the first design input to post-market surveillance, every regulated process a device manufacturer owns lives in one connected system — no bolt-on tools, no spreadsheets holding your evidence together.
- Quality system: document control, change orders, CAPA, nonconformance, training, suppliers, complaints, audits, management review
- Regulatory: submissions, registrations, technical documentation, standards monitoring and change impact
- Clinical and evidence: study operations, investigations, literature and real-world evidence
- Design and device records: design controls, risk management, UDI and labelling
Built against US and international standards
Every workflow is modelled on the requirements your inspectors and notified bodies actually cite, so the same record set satisfies more than one market.
- FDA 21 CFR Part 820 / QMSR
- 21 CFR Part 11
- ISO 13485:2016
- ISO 14971
- EU MDR 2017/745
- EU IVDR 2017/746
- ISO 14155
- MDSAP
- ISO/IEC 27001
- EU GDPR / UK GDPR
- HIPAA
- UK MDR / UKCA
- Health Canada, TGA, PMDA
- ASTM / ANSI / ISO monitoring
Qevatrix supports compliance with these frameworks; conformity assessment and certification remain the manufacturer's responsibility.
Trust & compliance
Built to be inspected
The frameworks below are not a marketing list — each one maps to records, states and signatures inside the applications.
FDA 21 CFR Part 820 / QMSR
Design controls, CAPA, complaints and records modelled on the US quality system regulation.
21 CFR Part 11 signatures
Re-authenticated electronic signatures with meaning, timestamp and signer identity on every approval.
ISO 13485:2016 aligned
Document control, training, suppliers, audits and management review mapped to the standard's clauses.
EU MDR / IVDR ready
Technical documentation, PMS, PMCF and vigilance records structured for notified body review.
ISO 14971 & ISO 14155
Risk management files and clinical investigation records kept traceable to design and evidence.
EU GDPR & UK GDPR
Processor duties under Article 28, records of processing, data subject rights on a one-month clock, EU hosting and SCC-backed transfers.
Append-only audit trail
Every create, change, signature and export is recorded immutably and exportable for inspection.
Qevatrix supports compliance with these frameworks; conformity assessment and certification of your devices remain the manufacturer's responsibility.
FAQ
How Qevatrix supports US and international compliance
The questions quality, regulatory and clinical leaders ask us first.
How do Qevatrix apps support US FDA compliance?
Every quality process the FDA inspects — document control, design controls, CAPA, nonconformance, training, purchasing controls, complaints, audits and management review — is a first-class record in QualityOS with controlled state transitions, 21 CFR Part 11 electronic signatures and an append-only audit trail. Inspection exports include the approved revision, signature block, meanings, timestamps and the full history with a SHA-256 integrity hash.
Does the same record set satisfy EU MDR and other international markets?
Yes. Workflows are modelled against ISO 13485:2016, EU MDR 2017/745 and IVDR 2017/746, ISO 14971, ISO 14155, MDSAP, UK MDR/UKCA and the requirements of Health Canada, TGA and PMDA. Because all seven applications share one tenant and one record set, a single technical file, risk file or clinical dataset can be reused across markets instead of being rebuilt per submission.
Do I need seven separate systems, or is one enough to run the company?
One is enough. QualityOS, RegulatoryOS, DeviceOS, ClinicalOS, StudyOS, EvidenceOS and TrademarkOS cover the regulated lifecycle from design input to post-market surveillance on the same spine, so there are no exports, re-keying or reconciliation steps between quality, regulatory and clinical work.
How is AI used without compromising compliance?
Qevatrix Intelligence drafts text, cross-references records and flags inconsistencies. It never approves, closes or signs anything: every regulated outcome requires a qualified human to review, approve and sign, and the audit trail always names that person.
How do you keep us current when standards change?
The Standards Monitoring module watches ASTM, ANSI and ISO editions nightly, records edition changes on your watchlist and links them to the documents, risk files and submissions they affect so change impact assessments start with evidence rather than a search.
How does Qevatrix handle GDPR and patient privacy in the EU and UK?
Qevatrix acts as your processor under an Article 28 data processing agreement that includes the EU Standard Contractual Clauses and the UK International Data Transfer Addendum. EU and UK workspaces are hosted in EU regions, clinical uploads are de-identified at import, and access, rectification, erasure, restriction, portability and objection requests are recorded with a one-month response clock. Personal data breaches are reported to affected workspace owners within 24 hours so you can meet the 72-hour supervisory authority duty, and regulated records kept under Article 17(3) are documented in the retention register.
Is the software validated for regulated use?
Qevatrix ships validation support including executable IQ/OQ protocols, configuration records and traceable release notes. Conformity assessment and certification of your devices remain the manufacturer's responsibility; Qevatrix supports compliance with the frameworks listed above.
Why Qevatrix
Compliance is the architecture, not a feature
Regulated by design
Append-only audit trails, 21 CFR Part 11 electronic signatures, versioned records and controlled state transitions are built into the data model — not layered on afterwards.
AI that drafts, never decides
Qevatrix Intelligence writes first drafts, cross-references records and surfaces inconsistencies. Every regulated decision still requires a qualified human to review, approve and sign.
One tenant, every application
A single identity, permission model and organisation record spans every Qevatrix application. Activate a module and it reads the data you already have.
See it against your own quality system.
We will walk your team through document control, CAPA and audit readiness using scenarios from your device portfolio.