Assistance for Conformity Assessment of AI Innovations in Healthcare
Service for the creation of a practice-oriented reference documentation ("Blueprint") for the conformity assessment process of AI applications in healthcare within the framework of the "AI Real-World Laboratories for Healthcare" initiative. The service will be provided as a contract for work and includes the preparation of regulatory issues at the interface between the EU AI Regulation (AI-VO / AI Act) and other requirements such as the EU Medical Devices Regulation (MDR/IVDR). Highly specialized profiles ("Expert") with in-depth regulatory and technical expertise in the field of software medical devices and AI development are required. The scope is divided into 7 lots (verification/validation, data protection, risk management, cybersecurity, dynamic AI, third-party AI, post-market surveillance) with a project duration of approx. 3 months.
Bundesministerium für Gesundheit
·Bonn