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Tag: medical devices

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AER19 Blog Squad: The Confusion of Mobile Medical Devices

(PRIM&R) Public Responsibility in Medicine and Research

Back in 2004, before I started working for the Emory University IRB, I was working as a research coordinator in…

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PRIM&R’s Response to FDA’s Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device

(PRIM&R) Public Responsibility in Medicine and Research

In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.