Integrating AI into Regulated Software Development Cycles

The session features Ketryx experts Bailey Canter and Tim Brodeur, who will examine practical applications of AI across the software development lifecycle. By drawing on operational data from four of the top five medical device manufacturers, the discussion focuses on integrating AI into requirements generation, risk analysis, and test coverage. The core of the presentation centers on a 'human-in-the-loop' framework, which the speakers argue is essential for maintaining control within complex, high-stakes environments.

Attendees will explore structural shifts, specifically the transition to team-based 'pods,' designed to minimize traceability gaps. The webinar, scheduled for 10am EDT, provides a roadmap for organizations seeking to accelerate development speed while ensuring every automated step remains audit-ready.