Seth Kuzdzal

Company: Biofourmis

Job title: Former Senior Vice President, Quality Assurance & Regulatory Affairs

Seminars:

Demystifying AI Transparency: Building Systems That Regulators Trust 2:00 pm

Addressing the challenges of designing and developing AI/ML enabled medical devices that ensure transparency and meet FDA global regulatory expectations Navigating multi-region submission complexities, including FDA, EU MDR, and Japan, with a focus on AI-specific guidelines and clinical data requirements Integrating post-market surveillance insights to refine AI models, mitigate risks, an enhance regulatory readiness in…Read more

day: Day One Lunch & Networking