Andrew O’Keeffe
Executive Director - Global Digital Quality Olympus
Andrew O’Keeffe is Executive Director of Global Digital Quality at Olympus, leading quality strategy for cutting-edge medical device and digital health technologies. A champion of secure software development, he specializes in IEC 62304, IEC 82304, ISO 14971, and global regulatory standards, building scalable quality systems for AI-driven healthcare innovation.
Seminars
Tuesday 21st July 2026
Workshop B: Navigating FDA Guidance: Practical Threat Modeling & Security Architecture for Medical Devices
11:00 am
Interactive, scenario-based working session combining short expert framing talks with small-group exercises. Attendees work through a realistic device scenario and leave with a reusable threat modeling and security design framework
- Step-by-step walkthrough of how to build a regulator-ready threat model and map real cybersecurity risks to concrete security architecture decisions for a connected medical device
- Practical guidance on linking threats, controls, and verification evidence so cybersecurity work is clearly traceable and defensible in FDA submissions
- Attendees leave with a repeatable framework and documentation approach they can apply immediately to strengthen their own device security design and reduce regulatory pushback
