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[Seminar/Training] Introduction to AI Systems in Medical Devices (AI in Medical Engineering)

テュフズードジャパン 東京本社

AI (Artificial Intelligence) and Machine Learning (ML) are rapidly being utilized in the field of medical devices, expanding applications in various areas such as diagnostic support and image analysis. On the other hand, the development and market introduction of medical devices equipped with AI systems present design, evaluation, and operational challenges that differ from traditional medical devices. In this seminar, we will clearly explain the overall picture and basic concepts of AI medical devices, focusing on safety aspects. Participants will gain foundational knowledge useful for practical work by taking a comprehensive view from development to post-market. <Seminar Topics> - What is Machine Learning - Important considerations regarding the regulation of AI systems [CS3.1] - Risk management and corrective and preventive actions (CAPA) for AI systems - GMLP – Lifecycle of AI/ML-equipped medical devices