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

Bridging Consulting launches "Alexis and Ethan Explain It All" podcast, exploring FDA Digital Health, Generative AI, and healthcare innovati

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).

FDA's guidance on postmarket change controls for 510(k) software modifications ensures SaMD changes maintain safety and compliance.

Yu Zhao co-hosted a panel on AI-based medical device regulations at MedCon 2022, discussing EU AI Act and U.S. FDA framework for SaMD.