Yu Zhao, Founder and President of Bridging Consulting, participated the International Regulatory Science Forum 2024 – Navigating Digital Health Product Development Amid Eovling FDA Regulations, as a part of the University of Southern California (USC), Department of Regulatory and Quality Sciences delegation. Yu delivered a plenary lecture and hosted multiple workshops during March 12-14, 2024 conference hosted by Faculty of Pharmacy at Mahidol University, Bangkok, Thailand. The conference attendees ranges from regulators, academics to industry professionals, from Thailand, the United States, Taiwan and other Asian countries.
Plenary Lecture: FDA Clinical Validation Requirements for AI/ML-Enabled Medical Devices
Workshop: The Q-submission Program
Workshop: Software as a Medical Device (SaMD)
Workshop (co-hosted with Dr. Mary Wilhelm): AI/ML-Enabled Medical Devices
Workshop: 510(k) vs. De Novo Process
The conference concluded with a visit to Mahidol Engineering Innogineer Studio on March 15, 2024.
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