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
- Oct 13, 2023
- 6 min
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
- Oct 4, 2023
- 5 min
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
- Sep 12, 2023
- 1 min
Implementing a PCCP for Class II SaMD Products Beyond AI/ML
This white paper provides a comprehensive analysis of the PCCP,
with practical insights into implementation priorities and approaches.
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