Yu Zhao, Founder and President of Bridging Consulting, co-hosted a panel discussion on the topic of “Global Developments in Regulating AI-Based Medical Devices” with Gert Bos, PhD, FRAPS, CSO at Qserve Group and Eric Henry Senior Quality & Regulatory Compliance Advisor at King & Spalding, at the 2022 MedCon Conference, AFDO/RAPS Healthcare Products Collaborative.
The panelists discussed topics ranging from EU AI Act, U.S. FDA framework for artificial intelligence/machine learning (AI/ML) software as a medical device (SaMD), standards, to risk management and impact to quality management systems.
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