Geethapriya (Priya) Setty
Geethapriya (Priya) Setty MS MBA RAC PMP, is a manager of global regulatory affairs at Hologic, specialising in regulatory strategy, regulatory intelligence and digital health/AI compliance for high-risk devices. She has more than eight years of regulatory affairs experience and over twenty years in healthcare, including prior work as a pediatric occupational therapist. She is RAC Devices-certified and can be reached at onlypriyask@gmail.com.
JournalFrom gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
Rapid advances in AI, software and drug discovery are reshaping regulation. This article challenges the view that regulation hinders innovation, framing it as a collaborative, risk-based partnership with real-world examples from AI diagnostics, in silico methods and medical device tools.