Three Countries, Three Continents: AI Medical Device Regulation and Certification Comparison in the US, EU, and South Korea

Kanjar de, Alireza Salehi M.. Three Countries, Three Continents: AI Medical Device Regulation and Certification Comparison in the US, EU, and South Korea. In Ghada Zamzmi, Annika Reinke, Ravi Samala, Meirui Jiang, Xiaoxiao Li, Holger Roth, Mariia Sidulova, Thijs Kooi, Shadi Albarqouni, Spyridon Bakas, Nicola Rieke, editors, Bridging Regulatory Science and Medical Imaging Evaluation; and Distributed, Collaborative, and Federated Learning - First International Workshop, BRIDGE 2025, and 6th International Workshop, DeCaF 2025, Held in Conjunction with MICCAI 2025, Daejeon, South Korea, September 23 and September 27, 2025, Proceedings. Volume 16135 of Lecture Notes in Computer Science, pages 36-45, Springer, 2025. [doi]

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