Dr. Staci Kearney is a regulatory consultant and Founder of Elevation Strategic Development. She joins the show to discuss her unique path to the regulatory field as someone with a scientific background. In the last 5 years, the DP/AI industry has experienced the milestones of the first whole slide imaging system approved for primary diagnosis and the first AI algorithm approved as an aid to diagnosis. Dr. Kearney discusses the role of regulatory professionals in the industry and outlines the areas where vendors typically seek assistance from consultants. Finally, with the legislation surrounding In Vitro Diagnostics and DP/AI rapidly changing, Dr. Kearney breaks down the most impactful regulatory updates.
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