Yu Zhao12 jul9 Min. de lecturaarticlesData-Driven Trends In Predetermined Change Control PlansData-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.
Yu Zhao13 oct 20236 Min. de lecturaarticlesPart III: SaMD PCCP Implementation Beyond AIML: Considerations & ChallengesThis article provides tips and practical considerations for PCCP implementation.
Yu Zhao4 oct 20235 Min. de lecturaarticlesPart I: Medical Device Postmarket Change Controls and FDA 510(k) Software Modification GuidanceFDA's guidance on postmarket change controls for 510(k) software modifications ensures SaMD changes maintain safety and compliance.
