Where is patient data hosted?

Exclusively in EU data centres in Vienna and Frankfurt with cloud providers certified to BSI C5. 100% GDPR-compliant. The full technical architecture — including the confidential-computing layer and trusted execution environments — is shared with qualified prospects under NDA.

Is there an MDR classification?

No. None of the MiraNext modules is certified as a medical device under MDR (EU 2017/745) or intended for medical use within the meaning of the MDR. No MDR conformity assessment is initiated. Components such as the web viewer are expressly labelled as a reference and preview implementation for non-diagnostic purposes. Diagnostic image reading is performed on separately certified reading workstations by the physician.

How is AI billing calculated?

Per study — transparently itemised. You pay exactly for what MiraScribe or MiraNext AI processes for you. The Professional plan includes a monthly volume bundle; beyond that we bill per report. No flat rates by design. Concrete rates are set in the intro call.

Can we migrate from a legacy RIS?

Yes. We migrate structured data, DICOM studies and reports from the common RIS and PACS systems. Migration is part of onboarding and contractually backed by success criteria.

How long does roll-out take?

Typically 4–8 weeks per module. RIS+PACS first, then AI automation, then patient/referrer portal. Stoppable after each step.

MiraNext

Security & Compliance — souveräne Patientendaten

ISO 27001, ISO 42001, BSI C5 EU-Hosting, kontinuierliche Pen-Tests mit unabhängigem Drittauditor, EU AI Act, NIS2-ready.

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