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Journal Articles

Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework

Sanju Kaladharan, Dhanya Manayath, Rejikumar Gopalakrishnan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Review Articles
J. Med. Devices. December 2024, 18(4): 040801.
Paper No: MED-24-1065
https://doi.org/10.1115/1.4066280
Published Online: September 19, 2024
View Article titled, Regulatory Challenges in AI/ML-Enabled Medical Devices: A Scoping Review and Conceptual Framework
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Topics: Artificial intelligence, Computer security, Health care, Machine learning, Medical devices, Sustainability, Economics , Regulations, Safety, Health systems
Includes: Supplementary data