What it sells
RegTech.
Business model breakdown
Buyer: who owns the budget?
UnverifiedRegulatory/quality heads or founders at MedTech and IVD companies (hypothesis).
Trigger: what makes them buy now?
Need for CE marking under MDR/IVDR with regulatory uncertainty, fragmented documents and unpredictable cost/timelines.
Workflow: what inputs become what output?
Three services: Regulatory Compass (qualification, classification, pathway), Technical File Readiness (technical documentation, clinical evidence, labelling, consistency checks), Lifecycle Compliance (monitoring, change impact, post-market surveillance); AI drafts, expert reviews.
Economics: what it saves and how it charges
Fixed-cost, defined-timeline services.
Distribution: how it reaches customers
Demo booking.
Funding history and coverage
| Round date | Stage | Amount | Investors | Source |
|---|---|---|---|---|
| 2026-10-06 | Pre-seed | €150K | — | news.google.com |
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.