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Yu Zhao
2024年9月17日読了時間: 1分
Bridging Consulting at USC’s Medical Device Risk Management Training
Bridging Consulting joined USC's event on medical device risk management, where founder Yu Zhao shared insights on AI/ML-enabled devices.
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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
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4日読了時間: 5分
Part I: Medical Device Postmarket Change Controls and FDA 510(k) Software Modification Guidance
FDA's guidance on postmarket change controls for 510(k) software modifications ensures SaMD changes maintain safety and compliance.
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