From Validated Event to Validated State: Governing AI That Changes After Deployment
Traditional validation answers one question: did the system perform as intended when it was tested? For decades, that question was sufficient, because software governed by fixed logic did not change its behavior once cleared. AI-enabled systems break that assumption. A model’s outputs are calculated from patterns in training data, and once real-world conditions diverge from that data, the system’s behavior can shift without a single line of code being touched — quietly, without triggering a change control, and often without anyone noticing until the consequences surface downstream.
This talk examines why that shift matters for regulated industries, using medical device software as the primary lens. It walks through two parallel cases — a sepsis prediction tool governed by design controls and PCCP, and a complaint-routing tool governed by Computer Software Assurance — to show how both experience the same failure mode despite sitting in different regulatory lanes. The session introduces a practical continuous assurance framework built on three controls: predefined change boundaries, continuous monitoring for drift, and targeted reassessment, with qualified human oversight at the center of each. Attendees will leave with an operational model for keeping AI systems in a demonstrably validated state across their full operational lifecycle, not just at launch.
Moved from Stage ONE at 1:50. This adds a medical device manufacturer’s voice to the keynote block. Geethapriya is published in the RAPS Journal of Regulatory Affairs and closed a RAPS plenary this year.
About the speaker
Geethapriya Setty
Global Regulatory Affairs Manager at Hologic
Geethapriya (Priya) Setty is a regulatory affairs strategist and systems builder with a deep belief in purpose-driven innovation. With over nine years of experience in global regulatory affairs and more than decade in healthcare, she brings a unique blend of clinical insight and policy expertise to the evolving world of medical technology.Starting her career as an occupational therapist, Priya’s focus has always been on impact- adding life to years, not just years to life. Today, she leads regulatory intelligence and digital transformation initiatives at a global medical device company, where she designs scalable systems to track emerging regulations, accelerate compliance, and enable access to life-changing technologies. Her work includes spearheading the development of an AI-powered Regulatory Intelligence platform that cut manual effort by 94 percent and brought real-time insights to global regulatory teams. She has also led the enterprise-wide implementation of a global Regulatory Information Management platform, driving requirements gathering, process alignment, and change management to standardize regulatory data and submissions across her organization. She has supported cross-functional teams in advancing regulatory strategies for high-risk and breakthrough devices, contributed to early responses to policies like the EU AI Act and FDA’s evolving digital health guidance, and partnered across R&D, clinical, and quality functions to help build compliance into innovation from day one. Priya holds dual MBAs and is certified in RAC (Devices), PMP, ISO 13485 auditing, and medical device compliance. She thrives at the intersection of technology, policy, and strategy, and is known for her ability to bring clarity to complexity. Her mantra “make a choice, and make it happen” guides how she leads, builds, and mentors. Whether supporting teams through regulatory change or architecting AI-enabled solutions, she remains grounded in the mission that first drew her to healthcare: to serve, to simplify, and to make healthcare innovation more human.
Daljit Chaggar
Regional Vice President at NNIT, Inc.
Bio coming soon!