Demystifying AI Transparency: Building Systems That Regulators Trust

Time: 2:00 pm
day: Day One Lunch & Networking

Details:

  • 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 real-world applications

Speakers:

Seth Kuzdzal