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).
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Yu Zhao
Oct 4, 20235 min read
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.
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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.
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