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ViewAttendees 33

Sponsored Presentation: The Future of Change Management for Cloud-Based AI/ML Medical Software

Thursday, October 5, 2023
12:45 PM – 1:10 PM EDT
Location/Room: Exhibit Hall: Spark! Stage (Booth 323)
The rapid adoption of AI/ML in cloud-based medical software demands effective change management. This session explores the challenges posed by AI/ML in software and provides a framework to validate AI/ML-based applications, ensure FDA compliance, and prevent product development delays. 

Learning Objectives:

  • Understanding AI/ML validation challenges: Understand the challenges and opportunities in AI/ML validation and refine your team’s SOPs.
  • Get the latest on FDA Requirements: Learn about FDA expectations and relevant guidances to AI/ML in medical software including the April 2023 draft guidance, Marketing Submission Recommendations for a Predetermine Change Control Plan for AI/ML-enabled device Software Functions.
  • Effective change management strategies for RA teams: Learn best practices tailored for Regulatory Affairs teams confronting the reality of incorporating AI/ML into medical device software. The focus will be on strategies that ensure FDA compliance and enable rapid, responsive, and reliable change management.