The eQMS that finds your compliance gaps — and drafts the fixes.
Tell us about your device. We'll determine which US and EU standards apply, where your documentation falls short, and draft the missing pieces — every claim cited, and nothing approved until your team signs it.
No credit card · 2 seats and your first device project, free.
Glucose Monitor v2 — readiness
FDA II · MDR IIa3 gaps · AI drafts ready for review — nothing approved without sign-off.
How it works
From device description to audit-ready drafts
One guided workflow across both markets — you stay in control at every step.
Profile the device
Describe intended use, markets, and software — once.
Dual classification
Get FDA and EU MDR class with rationale and citations.
Gap analysis
Every requirement scored MET / PARTIAL / MISSING.
Draft & sign off
AI drafts the gaps; your team reviews and e-signs.
Platform
Compliance, accelerated — not automated away
The AI proposes; your team decides. Every output is grounded, cited, and reversible.
One device, both markets
Gap analysis, grounded
Drafts you can trust
Audit-ready by design
Pricing
Plans that scale with your program
Start free. Both markets supported from day one; paid tiers unlock dual-market activation, more projects, and higher AI throughput.