PCCP | Bridging Consulting

Yu Zhao

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

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

Part III: SaMD PCCP Implementation Beyond AIML: Considerations & Challenges

This article provides tips and practical considerations for PCCP implementation.

Yu Zhao

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

Implementing a PCCP for Class II SaMD Products Beyond AI/ML

This white paper provides a comprehensive analysis of the PCCP, with practical insights into implementation priorities and approaches.

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