articles

Yu Zhao

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.

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.

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).

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.

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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