Qevatrix Multi OS
More Medical Device Projects. Less Complexity. One Connected Portfolio.
Your eQMS, regulatory work, clinical evidence and study management — one connected platform built for medical device companies.
- Part 11 Signature-ready
- ISO 13485 + MDSAP aligned
Every App. One Vision. Patent-Pending Innovation.
DeviceOS
Your quality system and regulatory work on one record.
- eQMS with Part 11 signatures
- Submissions and registrations
- One audit trail
Just need an eQMS? Start with QualityOS
Clinical Evidence Suite
From first study to post-market evidence.
- Study management
- Electronic data capture
- Registries and PMCF
Also from Qevatrix: RegulatoryOS, DistributorOS, ReimbursementOS, TrademarkOS. See all apps
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
- MDSAP (US, Canada, Australia, Brazil, Japan)
- ISO 14971
- EU MDR 2017/745
- EU IVDR 2017/746
- ISO 14155
- 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.
MDSAP audit-ready
One ISO 13485-based record set audited against the MDSAP model for the US, Canada, Australia, Brazil and Japan.
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 every Qevatrix app shares 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 a separate system for each job, or is one enough to run the company?
One is enough. Every Qevatrix app covers 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.
Is Qevatrix aligned for MDSAP audits?
Yes. QualityOS includes an MDSAP readiness path with chapter-by-chapter evidence evaluation covering the participating jurisdictions — United States, Canada, Brazil, Australia and Japan. The tracker maps required procedures, management reviews, design controls, risk management, post-market surveillance and corrective action evidence to MDSAP audit expectations. Qevatrix supports your MDSAP preparation; third-party certification and audit outcomes remain your responsibility.
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.