Yu Zhao's article, "Decoding FDA's Final PCCP Guidance," analyzes its impact on AI-driven medical devices and combination products.

Bridging Consulting releases Episode 6 of "Alexis and Ethan Explain It All," exploring FDA's final PCCP guidance for AI-enabled devices.

Yu Zhao and Dr. Naveen Agarwal explore PCCPs on "Let’s Talk Risks!", discussing strategies to accelerate medical device market entry.

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

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

Yu Zhao joined a panel hosted by Orthogonal discussing how PCCP accelerates AI algorithm updates, FDA policies, and best practices.

This article provides tips and practical considerations for PCCP implementation.

This article deciphers the new U.S. laws around Predetermined Change Control Plans (PCCP).