Regulated medtech.
You are the customer base — not a vertical we also serve. Qeino's deployment model, Ledger and founder-market fit are shaped to this sector.
Class IIb and III device submissions, IEC 62304 software lifecycle and notified-body audits do not tolerate late surprises. A traceability gap discovered in week eleven is a submission slip, not a sprint issue.
MDR, ISO 13485 and IEC 62304 govern the lifecycle. Patient data and design history files cannot leave the controlled environment under any vendor pretext.
On-prem inside the QMS-controlled network. Read-only access to design controls, verification evidence and risk files. Every Qeino read is auditable for the notified body.
The founders have operated under notified-body review and lived the cost of a late finding. The Ledger's audit posture is built for that scrutiny.
One posture, four regimes.
How this sector sits against the four regimes that matter.
Medical-device AI is high-risk. In-perimeter operation keeps the manufacturer as provider of record.
Applies to large medtech operators. The deployment model satisfies essential-entity control requirements.
Direct: IEC 62304 lifecycle, ISO 14971 risk, design-history-file traceability are first-class in the Ledger's audit trail.
Not in scope.
| Sector | EU AI Act | NIS2 | MDR | DORA |
|---|---|---|---|---|
| Semiconductor | Applies | Applies | Out of scope | Out of scope |
| Regulated medtech | Applies | Applies | Direct | Out of scope |
| Defence-adjacent (EU) | Applies | Applies | Out of scope | Out of scope |
| Deeptech | Inherited | Inherited | Inherited | Inherited |
The bar is rising. The window is short.
MDR transition timelines and increasing notified-body backlog mean late-knowledge gaps now compound directly into market-access delay.
Know what is about to break. Inside your perimeter.
Run a Foresight Pilot shaped to regulated medtech — measured from day one, sovereign by construction.