For years, many regulated product teams kept AI at arm’s length while it became mainstream elsewhere. Now, AI transformation initiatives are increasing pressure on individuals and organizations to adopt AI without weakening compliance, traceability or audit readiness.
This webinar explores high-value AI use cases across regulated SDLCs, from requirements generation, risk analysis, test coverage and change impact assessment to the human oversight needed to make AI-supported development effective. Drawing on lessons from four of the top five medical device manufacturers, the session will examine where AI can accelerate regulated product development while maintaining control across complex workflows.
Attendees will learn what an AI-native regulated SDLC can look like, how teams can structure work into pods to reduce traceability gaps and how human-in-the-loop workflows support compliant AI adoption.
Register for this webinar to learn how SDLCs can use AI to improve requirements, risk analysis and audit-ready development.
Speakers
Bailey Canter, Director of Solutions, Ketryx
Bailey Canter is a Systems Engineering professional with deep expertise in complex systems development and cross-functional technical leadership. Currently serving as the Director of Solutions at Ketryx, she helps life sciences teams navigate the intersection of systems engineering principles and regulated software development to improve quality and accelerate product delivery. Prior to joining Ketryx, Bailey worked as a Systems Engineer leader at Raytheon Technologies, where she led 15 Software Engineers on the company’s premier radar program. Bailey previously served as Scrum Master at Amwell, a leading telehealth platform, where she led three agile software teams. Bailey holds a Bachelor of Science degree from the University of North Carolina at Chapel Hill.
Message Presenter
Tim Brodeur, VP, Success & Delivery, Ketryx
Tim Brodeur is the Vice President of Success & Delivery at Ketryx, leading strategy and operations to drive strong customer outcomes. He previously served as VP of Customer Success at Causaly and held leadership roles at Benchling and Veeva Systems, building and scaling customer success teams for complex scientific and technology organizations.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Quality and Regulatory leaders exploring how to use PCCPs to manage software and AI changes without repeated submissions, while maintaining audit readiness
- R&D and Engineering teams looking to adopt CI/CD in regulated environments and accelerate releases without getting slowed down by manual validation, documentation and change control
- AI and Innovation teams building AI/ML-enabled products who want a compliant path to continuously update models using PCCPs and integrate retraining into CI/CD workflows
What You Will Learn
- What AI-native regulated SDLC looks like and how to start building toward it
- How to structure teams into pods so AI accelerates work without creating traceability gaps or audit risk
- What it actually means to have humans in the loop, and how to build workflows around it
Xtalks Partner
Ketryx
Ketryx transforms the product lifecycle for life science teams, enabling faster, safer releases. Trusted by three of the top five medical device makers, its AI-native platform overlays existing tools to automate documentation, ensure traceability, and cut manual work by 90%—boosting compliance, quality, and speed without disrupting current workflows. Learn more at ketryx.com.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account