Regulatory Implications of AI & Code Generation in Medical Device Software Development

• Go through what teams must do to verify, validate, and keep traceability when AI tools help write software
• How to manage tool reliability, version changes, and documentation so AI-generated code remains testable and compliant
• Practical governance, human oversight, and documentation practices that allow safe use of AI while meeting regulatory expectations

Speakers:

Gerald Rigdon

Fellow, Software Engineering

Boston Scientific Corporation