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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
Journal Articles

Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience

Jan B. Pietzsch, Marta G. Zanchi, John H. Linehan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Research Papers
J. Med. Devices. June 2012, 6(2): 021015.
https://doi.org/10.1115/1.4006781
Published Online: May 24, 2012
View Article titled, Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
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Topics: Food and Drug Administration, Medical devices, Regulations
Journal Articles

The Characteristics of Innovative, Medical Devices

Katja Holtta-Otto, Matthew Saunders, Carolyn Seepersad
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Design Of Medical Devices Conference Abstracts
J. Med. Devices. June 2010, 4(2): 027519.
https://doi.org/10.1115/1.3443171
Published Online: August 10, 2010
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Topics: Medical devices, Design, Biomedical engineering, Biomedical equipment, Design methodology, Engineering design, Innovation, Mechanical engineering, Product design, Regulations