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.
Download the white paper: Implementing a PCCP for Class II SaMD Products Beyond AI/ML.
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