Data-Driven Trends In Predetermined Change Control Plans
Data-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.
top of page
Yu Zhao
Mar 151 min read
Yu Zhao Joins USC Delegation at International Regulatory Science Forum 2024
Yu Zhao delivered a plenary lecture and hosted workshops on FDA regulations at the International Regulatory Science Forum 2024.
11 views0 comments
Yu Zhao
Oct 10, 202311 min read
Part II: Deciphering New US Laws Around Predetermined Change Control Plan
This article deciphers the new U.S. laws around Predetermined Change Control Plans (PCCP).
13 views0 comments
Yu Zhao
Sep 12, 20231 min read
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.
5 views0 comments
bottom of page