Ashley Miller
Director, Regulatory Affairs Hologic
A seasoned Regulatory Affairs leader, she currently serves as Director of Regulatory Affairs at Hologic, following senior leadership roles at Digital Diagnostics and ICU Medical. She specializes in global regulatory strategy, FDA engagement, digital health, and complex device submissions, guiding cross-functional teams to achieve compliant, market-ready medical innovations worldwide.
Seminars
Wednesday 22nd July 2026
Mastermind: Modern Operating Models for Medical Device Software, Delivering Compliant Products Faster
9:00 am
- 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
Thursday 23rd July 2026
Fireside Chat: Beyond Accuracy: Strategies for Post-Market Monitoring & Real-World Performance of AI Models
3:30 pm
- The gap between algorithm performance and deployable medical products
- Regulatory, usability, and reimbursement barriers that stall innovation
- Lessons from companies that successfully crossed the “last mile”
- What investors, regulators, and customers now expect from software-driven devices
