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Yu Zhao
2024年12月9日読了時間: 1分
Bridging Consulting’s Insights on FDA’s Final Guidance on PCCPs Featured on Leading Platforms
Yu Zhao's article, "Decoding FDA's Final PCCP Guidance," analyzes its impact on AI-driven medical devices and combination products.
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Yu Zhao
2024年12月3日読了時間: 1分
Episode 6 – Exploring FDA Final Guidance on PCCPs
Bridging Consulting releases Episode 6 of "Alexis and Ethan Explain It All," exploring FDA's final PCCP guidance for AI-enabled devices.
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Yu Zhao
2024年11月1日読了時間: 1分
Exploring PCCP Opportunities and Challenges with Dr. Naveen Agarwal
Yu Zhao and Dr. Naveen Agarwal explore PCCPs on "Let’s Talk Risks!", discussing strategies to accelerate medical device market entry.
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Yu Zhao
2024年7月12日読了時間: 9分
Data-Driven Trends In Predetermined Change Control Plans
Data-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.
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Yu Zhao
2024年6月28日読了時間: 1分
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
2023年10月13日読了時間: 6分
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
2023年10月10日読了時間: 11分
Part II: Deciphering New US Laws Around Predetermined Change Control Plan
This article deciphers the new U.S. laws around Predetermined Change Control Plans (PCCP).
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Yu Zhao
2023年9月12日読了時間: 1分
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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