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Integrating AI into Regulated Software Development Cycles

Medical device manufacturers face a mounting challenge: scaling AI adoption while satisfying rigorous compliance and audit requirements. A July 14 webinar hosted by Xtalks aims to bridge this gap, detailing how teams can leverage AI tools for development without compromising traceability or regulatory standing.

Integrating AI into Regulated Software Development Cycles
Photo: Bio & News

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.

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