qualityos.qevatrix.com
Qevatrix QualityOS
An AI-native eQMS that people actually want to use.
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.
Document control
Controlled SOPs and forms with revisions, approvals and effective dates.
OpenCAPA
Containment, investigation, actions and effectiveness verification.
OpenNonconformance
Detection, disposition and linked corrective action.
OpenRisk management
ISO 14971 risk files, hazard analysis and residual risk control.
OpenDesign controls (DHF)
Design inputs, outputs, V&V, reviews and the traceability matrix.
OpenTraining
Role-based curricula and read-and-understood records.
OpenTraining matrix
Gaps by role and person across every required curriculum.
OpenSupplier management
Approved supplier list, risk and re-evaluation.
OpenSupplier audits
Audit programme, results, scores and live supplier scorecards.
OpenCustomer complaints
Intake, reportability assessment and resolution.
OpenPost-market surveillance
Vigilance decisions with 30/15/2-day regulator clocks and submissions.
OpenAudits
Schedules, findings and inspection-ready evidence.
OpenAudit schedule
Twelve-month programme of internal and supplier audits.
OpenEquipment & calibration
Calibration intervals, certificates and out-of-tolerance handling.
OpenLot release (DHR)
Device history record review and controlled batch release decisions.
OpenValidation (IQ/OQ/PQ)
Software and equipment qualification evidence for intended use.
OpenManagement review
Clause 5.6 inputs, decisions, sign-off and exportable minutes.
OpenInspection readiness
One-click indexed evidence pack for an inspector or notified body.
OpenRecords retention
Retention periods per record type and legal holds.
OpenStandards monitoring
ASTM, ANSI, ISO and IEC edition watch.
OpenTrending
Quality metrics and signal detection across modules.
OpenRegulatory frameworks covered
One record set, multiple markets. Documents, CAPA, complaints, audits and management review are modelled against each of the frameworks below, and the AI reviewer and assistant cite them directly.
United States
FDA QSR / QMSR and Part 11
21 CFR 820 (QMSR, 21 CFR 820.10), 21 CFR Part 11, 21 CFR 803, 21 CFR 806
Electronic records and signatures, complaint handling, MDR reporting and corrections/removals.
International
ISO 13485:2016
ISO 13485:2016 (Amd 1:2021), ISO 14971:2019
Core QMS process model shared by every market below.
European Union
EU MDR 2017/745 & IVDR 2017/746
MDR Article 10(9), Annex IX Chapter I, Articles 83–86 (PMS, PSUR), Article 87 (vigilance)
QMS elements required for CE marking: post-market surveillance plan, PMCF, PSUR, vigilance and FSCA reporting to competent authorities and Eudamed, plus PRRC responsibilities.
Canada
Health Canada CMDR
CMDR SOR/98-282 (s.34–43, s.57–61.4), ISO 13485:2016
Mandatory problem reports within 10/30 days, recall reporting, distribution records and licence amendment triggers.
International
Medical Device Single Audit Program (MDSAP)
MDSAP Audit Approach, current edition; ISO 13485:2016
Single-audit coverage for the participating regulatory authorities in Australia, Brazil, Canada, Japan and the United States.
United Kingdom
UK MDR 2002 / UKCA
UK MDR 2002 (SI 2002/618), MHRA vigilance guidance (MORE), UK Responsible Person duties
UKCA conformity route, UK Approved Body oversight, MHRA incident and FSCA reporting timelines and UK Responsible Person records for non-UK manufacturers.
European Union / United Kingdom
EU GDPR 2016/679 & UK GDPR
GDPR Art. 5, 6, 9, 15–22, 28, 30, 32–34, Chapter V (SCCs), UK GDPR & Data Protection Act 2018
Personal data protection: lawful basis and Article 9 conditions for health data, data subject rights on a one-month clock, Article 28 processor duties, records of processing, security of processing, EEA transfer safeguards and 72-hour breach notification.