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Terry Irwin

Sr. Distinguished Engineer - Edwards Lifesciences

Demystifying AI and ML: A Practical Framework for Risk Management

This session begins with an engaging demonstration that reveals how artificial intelligence can be faked to expose common AI myths and misconceptions. These myths are then contrasted with reality, setting the stage for a clear and accessible introduction to how AI and machine learning actually work. Attendees will learn the basics behind AI training methods, the principles behind neural networks, and how mathematics and statistics drive the outputs generated by AI systems.

Building on this foundation, the second part of the presentation explores AI risks and the controls recommended by leading frameworks, including the EU AI Act, NIST AI Risk Management Framework, and AAMI TIR34971. This discussion emphasizes the importance of responsible and ethical application of AI technologies in regulated environments.

The session concludes with a practical AI management framework based on ISO 42001. This PDCA-based approach includes four key elements:

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  1.     Risk assessment and control

  2.     AI system oversight

  3.     Performance monitoring

  4.     Maintenance and correction


Attendees will gain actionable insights to guide responsible AI adoption, align compliance with innovation, and embed AI governance into existing quality management systems.

Thank you to
our sponsors

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