One identity. Every application.
The software layer for regulated medical device companies.
Qevatrix is an AI-native ecosystem for quality, regulatory, clinical and evidence operations. Seven applications, one record set, one audit trail — built for teams who have to defend every decision.
- 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.
Device manufacturers consolidating quality and regulatory operations
deviceos.qevatrix.comQualityOS
An AI-native eQMS that people actually want to use.
Quality and RA teams at device manufacturers, from startup to enterprise
qualityos.qevatrix.comRegulatoryOS
Submissions, registrations and regulatory intelligence in one place.
Regulatory affairs teams managing multi-market device portfolios
regulatoryos.qevatrix.comClinicalOS
Protocol to clinical study report, on one platform.
Sponsors and clinical operations teams running device investigations
clinicalos.qevatrix.comEvidenceOS
Real-world evidence and device registries, starting with spine.
Manufacturers, societies and consortia building device registries
evidenceos.qevatrix.comStudyOS
The operating platform for contract research organizations.
CROs and clinical service organizations managing multi-sponsor portfolios
studyos.qevatrix.comTrademarkOS
Trademark intelligence for regulated brands.
Brand, legal and IP teams inside regulated companies
trademarkos.qevatrix.comWhy 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.