Mastermind: Modern Operating Models for Medical Device Software, Delivering Compliant Products Faster

• Why traditional regulatory and quality models are struggling with AI and rapid software change
• How leading companies are restructuring teams across software, quality, regulatory, and cybersecurity
• The shift from “submission-focused” thinking to lifecycle accountability

Speakers:

Ashley Miller

Director, Regulatory Affairs

Hologic

Ganesh Kiran

Senior Principal Software Product Owner

Medtronic