The Gens & Associates Podcast

Executive Series: James Gianoutsos (Rimsys) - AI, Market Access, and the Future of Regulatory Work

August 31, 2026·40 min
Episode Description from the Publisher

Host Steve Gens sits down with James Gianoutsos, founder and CEO of Rimsys, for a wide-ranging discussion on how AI is reshaping regulatory work in medtech. They explore emerging market-access models, the shift toward AI-supported impact assessments, evolving validation expectations, and how regulatory teams are adapting to a rapidly changing digital landscape. If you'd like to learn more about Rimsys, check out their website: https://www.rimsys.io/

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