The Agile Advantage: Speed and Safety for AI/ML-Enabled Medical Devices

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.