Assistance for Conformity Assessment of AI Innovations in Healthcare
Provision of selected parts of documentation for the conformity assessment process of AI applications in healthcare: Creation of reference documentation for an AI application, which does not necessarily have to be a medical device, along with related services. The AI applications must be defined as AI systems according to the AI-VO and intended for (prospective) use in healthcare. The reference documentation and a statement will be published by the BMG or designated institutions for reuse, to facilitate and accelerate future conformity assessments; further details as per the tender documents.
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Tender documents
- Portal — LOT-0001NON-RESTRICTED-DOCUMENT
- TED HTML — 530791-2026HTML
- TED PDF — 530791-2026PDF
- TED XML — 530791-2026XML
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Lots (7)
- LOT-0001Verifizierung und Validierung für KI-Anwendungen im Gesundheitswesen
- LOT-0002Datenschutz für KI-Anwendungen im Gesundheitswesen
- LOT-0003Risikomanagement für KI-Anwendungen im Gesundheitswesen
- LOT-0004Cybersicherheit und Robustheit für KI-Anwendungen im Gesundheitswesen
- LOT-0005Dynamische KI-Anwendungen im Gesundheitswesen
- LOT-0006Drittanbieter-KI-Anwendungen im Gesundheitswesen
- LOT-0007Post-Market-Surveillance Dokumentation für KI-Anwendungen im Gesundheitswesen