Data-Driven Trends In Predetermined Change Control Plans
Data-driven trends show increased FDA authorization of PCCPs, enhancing SaMD compliance and postmarket change controls.
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Yu Zhao
28 jun1 Min. de lectura
Yu Zhao Joins Orthogonal Panel on Accelerating AI Algorithm Updates with PCCP
Yu Zhao joined a panel hosted by Orthogonal discussing how PCCP accelerates AI algorithm updates, FDA policies, and best practices.
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Yu Zhao
13 oct 20236 Min. de lectura
Part III: SaMD PCCP Implementation Beyond AIML: Considerations & Challenges
This article provides tips and practical considerations for PCCP implementation.
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Yu Zhao
10 oct 202311 Min. de lectura
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
4 oct 20235 Min. de lectura
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
3 may 20221 Min. de lectura
Yu Zhao Co-Hosts Panel on Global AI-Based Medical Device Regulations at MedCon 2022
Yu Zhao co-hosted a panel on AI-based medical device regulations at MedCon 2022, discussing EU AI Act and U.S. FDA framework for SaMD.
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