For EU MDR Class I & Class IIa SaMD teams

The no-stress QMS.

Audit-ready in days, not months.
QualiHQ generates your complete QMS in minutes. Review, approve, and ship.

How it works

Three steps to audit-ready

Describe your product

Paste your README, product spec, or a plain description of what your software does and who uses it. No special format required.

Add test evidence (or skip)

Upload test results from any CI pipeline or testing library. No CI yet? Skip it and add evidence later as your process matures.

Review, approve, and ship

Everything AI generates lands in a review queue. Approve what fits, adjust what doesn't. Nothing goes live until a human signs off.

Auto generated

Requirements, verifications, and risk items from your description

Auto linked

Every item connected to the test and release it belongs to

Auto verified

Test results matched and verified against requirements automatically

Built for how you work

Compliance without the chaos

Complete QMS, set up in days

Describe your product and upload test evidence. QualiHQ generates your requirements, verifications, risk register, and traceability chain. Review, approve, and your QMS is live.

Always audit-ready

Every release is automatically documented and linked to evidence. Walk into any audit with confidence. Your record is complete and always current.

Built for teams

Role-based access, approval workflows, and e-signatures built in. Your QA lead approves releases. Your engineers stay in their workflow.

Pricing

Start free. Upgrade when AI saves you more than it costs.

Free gives you AI setup for your first product and a fully functional manual QMS. No credit card required.

Free

€0

AI-generated setup for 1 product
Fully functional manual QMS
3 seats
15 AI-generated requirements & verifications
1 AI-assisted release
1 internal audit per year

From zero to audit-ready in days.

Start free. Early adopter pricing locked in for the first 50 customers.

Request access →