What it sells
AI platform automating medical device regulatory compliance, including technical documentation, quality management system documentation and audit preparation.
Business model breakdown
Buyer: who owns the budget?
Medtech regulatory affairs teams
Trigger: what makes them buy now?
Medical device certification (EU MDR) documentation burden
Workflow: what inputs become what output?
Technical documentation and audit preparation
Economics: what it saves and how it charges
SaaS subscription by tier (users, product families, jurisdictions, storage) plus onboarding fee and optional guided regulatory-expert services and Conformity Checks.
Distribution: how it reaches customers
Demo-led (Book a Demo) with published tier pricing; also sells to Notified Bodies; customer stories include OPED, Elixion, Munich Medical Devices.
Funding history and coverage
| Round date | Stage | Amount | Investors | Source |
|---|---|---|---|---|
| 2026-01-07 | — | €6.2M | Cusp Capital (lead), D11Z, Calm/Storm, UnternehmerTUM, nine business angels incl. Axel Stepken | tech.eu |
Profiles summarize public reporting and company websites. Business-model notes are MaxBC's reading of that material, not confirmed facts; unknowns are left blank rather than guessed. Updated 2026-10-12.