Assistance for Conformity Assessment of AI Innovations in Healthcare
Provision of reference documentation for AI applications in healthcare: selected parts of the usual documentation for conformity assessment processes, related to an AI application for healthcare (not necessarily a medical device), including further services for documentation creation (see section 1.2). The AI applications must be defined as AI systems according to the AI-VO and have an (anticipated) use in healthcare. The reference documentation and statement aim to facilitate and accelerate future conformity assessment processes and will be published by the BMG or designated institutions for reuse by third parties; further details as per the tender documents.
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Tender documents
- Portal — LOT-0001NON-RESTRICTED-DOCUMENT
- TED HTML — 590373-2026HTML
- TED PDF — 590373-2026PDF
- TED XML — 590373-2026XML
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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-0005Referenzdokumentation für dynamische KI-Anwendungen im Gesundheitswesen
- LOT-0006Referenzdokumentation für Drittanbieter-KI-Anwendungen im Gesundheitswesen
- LOT-0007Dokumentation für Post-Market-Surveillance von KI-Anwendungen im Gesundheitswesen