Data-Driven Trends In Predetermined Change Control Plans
Data-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.
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Yu Zhao
13 oct 20236 Min. de lectura
Part III: SaMD PCCP Implementation Beyond AIML: Considerations & Challenges
This article provides tips and practical considerations for PCCP implementation.
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Yu Zhao
4 oct 20235 Min. de lectura
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.
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Yu Zhao
12 sept 20231 Min. de lectura
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
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Yu Zhao
3 may 20221 Min. de lectura
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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