SaMD | Bridging Consulting

Yu Zhao

7月12日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

2023年10月13日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4日5 分

Part I: Medical Device Postmarket Change Controls and FDA 510(k) Software Modification Guidance

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

Yu Zhao

2023年9月12日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

Yu Zhao

2022年5月3日1 分

Yu Zhao Co-Hosts Panel on Global AI-Based Medical Device Regulations at MedCon 2022

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.

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