Implementing a PCCP for Class II SaMD Products Beyond AI/ML
This white paper provides a comprehensive analysis of the PCCP,
along with practical insights into implementation priorities and approaches
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Yu Zhao
6月28日讀畢需時 1 分鐘
Yu Zhao Joins Orthogonal Panel on Accelerating AI Algorithm Updates with PCCP
Yu Zhao joined a panel hosted by Orthogonal discussing how PCCP accelerates AI algorithm updates, FDA policies, and best practices.
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Yu Zhao
3月15日讀畢需時 1 分鐘
Yu Zhao Joins USC Delegation at International Regulatory Science Forum 2024
Yu Zhao delivered a plenary lecture and hosted workshops on FDA regulations at the International Regulatory Science Forum 2024.
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Yu Zhao
2023年10月13日讀畢需時 6 分鐘
Part III: SaMD PCCP Implementation Beyond AIML: Considerations & Challenges
This article provides tips and practical considerations for PCCP implementation.
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Yu Zhao
2022年5月3日讀畢需時 1 分鐘
Yu Zhao Co-Hosts Panel on Global AI-Based Medical Device Regulations at MedCon 2022
Yu Zhao co-hosted a panel on AI-based medical device regulations at MedCon 2022, discussing EU AI Act and U.S. FDA framework for SaMD.
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