AI in Post-Market Surveillance Working Groups
The AI in Post-Market Surveillance (PMS) Working Group, is a cross-functional initiative dedicated to advancing the safe, effective, and responsible use of artificial intelligence across post-market activities in regulated healthcare.
The Working Group develops practical frameworks, governance guidance, risk controls, and implementation resources that help organizations modernize post-market surveillance while maintaining regulatory compliance, quality, and patient safety. Through collaboration with industry, regulators, academia, and other stakeholders, the group is creating actionable guidance that supports AI readiness, responsible implementation, and scalable enterprise adoption.
The initiative is organized into three complementary workstreams.
Framework, Guidance & Readiness
Implementation Challenges & Risk Controls
Actionability & Enterprise Adoption
A dedicated Voice of the Customer (VOC) program co-led with the Quality Science Research Center (QSRC) engages stakeholders throughout the project to ensure all deliverables address real-world needs and implementation challenges.
Framework, Guidance & Readiness Working Group
Defines where AI can be integrated into post-market surveillance through future-state workflows, governance frameworks, and maturity models.
Working Group Leaders:
Implementation Challenges & Risk Controls Working Group
Develops approaches for validation, governance, risk management, and regulatory alignment.
Working Group Leaders:
Contributors:
Prakrit Subba, Medical University of South Carolina
Actionability & Enterprise Adoption Working Group
Focuses on implementation strategies, workforce readiness, and enterprise-scale adoption.
Working Group Leader:
Contributors:
Stan Chen, Kuzco Lighting
Kian Feiner, Glaukos Corporation
Reena Harjai, INOVIO Pharmaceuticals
Thi Nguyen, Whippet Systems
Bahram Saleh, Graduate Student
Plarent Ymeri, smartveeva