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.