top of page


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
12 jul 20249 Min. de lectura
2 visualizaciones
0 comentarios


Part III: SaMD PCCP Implementation Beyond AIML: Considerations & Challenges
This article provides tips and practical considerations for PCCP implementation.
Yu Zhao
13 oct 20236 Min. de lectura
2 visualizaciones
0 comentarios


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
4 oct 20235 Min. de lectura
4 visualizaciones
0 comentarios

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
12 sept 20231 Min. de lectura
1 visualización
0 comentarios
bottom of page