Solving the Agile Dilemma: Speed and Safety for AI/ML-Enabled Medical Devices

September 16, 2025
11:00 am EST
60 mins
Recorded on September 16, 2025

An agile approach promises speed, flexibility, and continuous improvement but regulated device development is slowed by lengthy documentation cycles and approvals. In a regulated setting, an agile workflow still requires that every iteration be tied to requirements, risks, and test evidence, and AI/ML-enabled devices add the extra challenge of retraining models, updating datasets, and revalidating performance with each change. This session explores how to adapt agile practices for regulated environments, including how CI/CD pipelines and AI agents can automate compliance tasks, preserve traceability, and keep quality in sync with faster, more frequent releases.

What you'll learn

• Key process changes needed to make agile work in a regulated environment
• Ways to embed automated testing, documentation, and traceability into each sprint
• Strategies for combining agile principles with CI/CD to support safe, continuous releases

Who should attend

Speakers

Maayan Shvo

Lead AI Engineer
Ketryx
Formerly

Bailey Canter

Director of Solutions
Ketryx
Formerly
Scrum Master, Amwell & Systems Engineer, Raytheon