How to Make Compliance Continuous for AI-Enabled SaMD

60

minutes

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Traditional quality workflows weren't designed for the rate of change that comes with AI and SaMD development. Continuous learning and model updates create challenges that most compliance systems aren't built to manage. This session covers what's actually shifting in how AI-enabled medical devices are evaluated and how to build a compliance approach that keeps pace with AI while meeting the requirements of the FDA, EU MDR, and the EU AI Act.

What you'll learn

• What continuous compliance looks like for an AI-enabled medical device and how to start building toward what a notified bodies looks for when evaluating AI model design, training data, and performance monitoring
• Where teams most commonly fall short when managing traceability and documentation as models update
• What AI and SaMD manufacturers get wrong in their documentation, and how to avoid the most common gaps