James Gianoutsos

James GianoutsosGens Associates2026-08-31T23:39:35+00:00

Gens & Associates Regulatory Executive Series Podcast

James Gianoutsos (CEO of Rimsys)

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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