For founders building health software
Not sure where to start with compliance?
You're in the right place.
Medical device QMS software · ISO 13485 · IEC 62304 · FDA & EU MDR
The no-stress QMS for SaMD teams.
Audit-ready in days, not months. QualiHQ drafts your 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
Founder-friendly QMS pricing.
Early adopters get the full founder QMS plus Compliance Course access for €49/month. Simple, affordable, and built for teams getting their first product audit-ready.
Founder
Early Adopter
€49/mo
Founder plan · 14-day free trial
- Unlimited products & seats
- Requirements, verifications, risks, and releases
- Document control, CAPAs, and complaints
- Internal audit and management review
- Compliance Course access
Scale
Early Adopter
€249/mo
Early adopter pricing · limited time
- Everything in Founder
- Unlimited products & seats
- Traceability export
- Priority support
Early adopter flat rates. See full pricing →
Building in Ireland?
Grant-funded medtech startups can often cover compliance tooling through Enterprise Ireland and EU funding. Here is what is available and how a QMS fits.
Explore startup grants for medtech founders →From zero to audit-ready in days.
See how QualiHQ builds your QMS, or find out where you stand first.