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Yu Zhao

Implementing a PCCP for Class II SaMD Products Beyond AI/ML

Actualizado: 4 ago

After attending the March 2023 SaMD (Software as a Medical Device) conference hosted by Orthogonal and MedSec, Yu Zhao, Founder and President of Bridging Consulting, chaired a working group of various industry SaMD experts to write a white paper. This white paper provides a comprehensive analysis of the Predetermined Change Control Plan as outlined in the Consolidated Appropriation Act of 2023, along with practical insights into implementation priorities and approaches.



white paper cover page
White paper: Implementing a PCCP for Class II SaMD Products Beyond AI/ML


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