PCCP | Bridging Consulting

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

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.

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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