For EU MDR Class I & Class IIa SaMD teams
AI-powered medical device QMS software for SaMD teams.
QualiHQ generates your requirements, verifications, SOPs, and traceability chain from your product description and test evidence. You review, approve, and ship. Audit-ready in days, not months.
Where QualiHQ saves your team time
Built to cut compliance overhead, not add to it
Biggest time saver
AI-linked traceability chain
Building a traceability matrix by hand, linking requirements to verifications to test cases to test runs, takes a compliance engineer weeks. QualiHQ generates the entire chain from your product description and test results. You review and approve it.
Release compliance warnings
Before you approve a release, QualiHQ flags everything an auditor would flag: unapproved requirements, missing test evidence, outstanding risk review, unreviewed dependencies, open critical issues. Catch it in your workflow, not in an audit finding.
Internal audit score
Run a gap check against ISO 13485 at any time. QualiHQ scores your QMS across requirements, risk, dependencies, training, documents, and your latest release, and links every gap directly to where you fix it. Know your audit readiness before an auditor walks in.
Ready-to-approve SOPs
All 10 required ISO 13485 procedures (Quality Manual, Risk Management, CAPA, Complaint Handling, and more) are generated on signup with your company name and placeholders for your specifics. Review and approve them in an afternoon, not a month.
Training records on autopilot
When you approve a document, training is automatically assigned to every team member who needs it. They mark it complete in QualiHQ. No chasing, no "did everyone read the new SOP?" conversation before an audit.
Design History File, per release
Each release captures its own DHF: the requirements you approved, the test evidence you linked, the risk review you signed off, and the dependency review. Everything is in place the moment you approve the release.
Getting started
Your first release, audit-ready in days
Describe your product
Paste in your README, product spec, or a plain description of what your software does and who uses it. Include your tech stack and any regulatory context you have. That's all QualiHQ needs to get started.
Add your test results (or skip for now)
Upload your automated test output from any testing library or CI pipeline. QualiHQ reads the results and links them to requirements. No CI pipeline yet? Skip this step and add test evidence later as your process matures.
Review, approve, and ship
Everything AI generates lands in a review queue. Approve what's right, adjust what isn't. Nothing goes live until a human signs off. Once approved, your QMS is complete, your traceability chain is built, and you are ready to release.
Then what?
Tools for the full QMS lifecycle
Setup is just the start. Your team uses QualiHQ to manage training records, track issues and CAPAs, review dependencies, handle complaints, and run internal audit gap checks. Every record in one place, linked to the release it belongs to.
Everything included
The full QMS lifecycle, covered
Requirements management
AI-generated or manual. Versioned, approved, linked to verifications. Unique IDs auto-assigned.
Verifications & testing
Test cases, manual executions, and automated test run imports. Pass/fail tracked per requirement.
Risk register
Product-level risk items with probability, severity, mitigation, and residual scores. Per-release sign-off.
Dependency management
SOUP inventory with risk levels, version tracking, and per-release review. Import from package.json, composer.json, and more.
Document control
Versioned SOPs with draft to approved lifecycle. Superseded versions retained. Approval logged with identity and timestamp.
Issues & CAPAs
Log issues, investigate root causes, manage corrective actions. Every record linked to the release and requirement it affects.
Complaint handling
Receive, triage, investigate, and close complaints. Escalate to CAPA when root cause is systemic. ISO 13485 §8.2.2 compliant.
Post-market surveillance
Track complaint and issue trends after release. Evidence that monitoring is happening, as required for ISO 13485 §8.2.1.
Electronic signatures
Guarded approval flows on every sign-off. Satisfies ISO 13485 electronic signature requirements.
Traceability matrix
Full requirement-to-evidence chain, always current. Filterable by status, feature, and release. Auditor-ready on demand.
Role-based access
Admins approve and manage. Members create and edit. Approval permissions configurable per person. No one approves their own work.
Standards coverage
Built for ISO 13485, IEC 62304 Class A, ISO 14971, and EU MDR Class I & IIa technical file requirements.
From zero to audit-ready in days.
See how QualiHQ builds your QMS, or find out where you stand first.