Postmarket | Bridging Consulting

Yu Zhao

7月12日讀畢需時 9 分鐘

Data-Driven Trends In Predetermined Change Control Plans

Data-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.

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.

Yu Zhao

2023年10月4日讀畢需時 5 分鐘

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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