Quality management that actually works
ClinixQM is the complete workspace for medical device and healthcare software teams. Manage documents, risks, CAPAs, training, and compliance evidence in one place. Get audit-ready faster.
Everything you need for regulatory compliance
From document control to audit packs, ClinixQM covers the full quality lifecycle for regulated products.
Document Control
Version-controlled documents with approval workflows. Draft, review, approve, and retire with full audit trail. AI-assisted writing helps you create compliant documents faster.
Risk Management
ISO 14971-aligned risk analysis with hazard identification, severity/probability matrices, and control measures. Link risks to requirements, tests, and verification evidence.
CAPA Management
Structured corrective and preventive action workflows. Root cause analysis, action tracking, effectiveness verification, and closure with evidence attachments.
Training Management
Assign training modules, track completion, and maintain training records. Automated reminders for recertification. Link training to document revisions.
Compliance Tracking
Map your work to regulatory requirements: UK MDR, EU MDR, FDA 21 CFR, ISO 13485, and more. Visual dashboards show your compliance status at a glance.
Audit Packs
Generate comprehensive evidence packages for auditors. Export documents, records, and traceability matrices. Share via secure, time-limited links.
Built for every role on your team
Whether you're managing quality, navigating regulations, building products, or running the business.
Quality Manager
Stay audit-ready with clear oversight of the entire QMS.
- Document lifecycle management
- CAPA tracking and closure
- Training compliance monitoring
- Audit preparation
Regulatory Affairs
Navigate global markets with confidence.
- Multi-market compliance mapping
- Submission binder assembly
- Regulatory intelligence
- Post-market surveillance
Engineering Lead
Build compliant products without slowing down.
- Design history file (DHF)
- Requirements traceability
- Change control integration
- Risk-informed development
Executive / Founder
See the big picture. Make informed decisions.
- Compliance dashboards
- Risk visibility
- Audit readiness scores
- Resource planning
Auditor
Access what you need, when you need it.
- Secure document access
- Evidence package review
- Finding documentation
- Time-limited access links
Clinical Safety Officer
Ensure patient safety is always the priority.
- Hazard log management
- Clinical risk assessment
- Safety case maintenance
- Incident tracking
Why teams choose ClinixQM
We built the system we wished existed when we were in your shoes.
Clarity, not complexity
Most QMS tools overwhelm you with features. ClinixQM guides you through exactly what you need to do, when you need to do it. Progressive disclosure means new users see a focused experience, while power users get full control.
Governance built in
Every action is logged. Every document version is preserved. Approval workflows are enforced, not suggested. When auditors ask questions, you have answers.
Multi-tenant isolation
Your data is logically isolated from other organizations. Server-side processing means no sensitive data touches the browser. Enterprise-grade security without enterprise-grade complexity.
AI that assists, not replaces
Our AI helps you write documents, identify risks, and summarize findings. But humans make the decisions. All AI processing happens server-side with no client-side API keys.
Ready to get audit-ready?
Start your free trial today. No credit card required.