PCCP | Bridging Consulting

Yu Zhao

7月16日讀畢需時 1 分鐘

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

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

6月28日讀畢需時 1 分鐘

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10日讀畢需時 11 分鐘

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).

了解更多详情？请联系我们。

我们非常愿意为您提供帮助。