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Postmarket Surveillance of AI Systems: Proactive methods for identifying risk and improving product quality

December 13, 2023
  •  
30
 minutes

This webinar provides actionable insights on navigating the post-market regulatory landscape and creating a process focused on patient safety for AI-enabled medical devices. It will focus on best practices, emerging threats, and the role of regulatory agencies in safeguarding data privacy and ensuring device security.

Learning objectives include:

  • Build a more efficient AI post-market surveillance with best practices and modern tools: Explore best practices for post-market surveillance to optimize AI devices for safer, more reliable outcomes.
  • Achieve regulatory success in Adaptive AI: Learn to navigate the intersection between post-market surveillance and regulatory requirements by addressing ongoing challenges for AI development and those trying to regulate it.
  • Prioritize safety by knowing when and how to engage with regulatory authorities for AI-related modifications: Understand at what point a modification to an AI device requires resubmission for FDA approval and how to communicate with regulatory authorities throughout the process.

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