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Medical Product Safety & Effectiveness Institute

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05

First-Principles Safety & Effectiveness Engineering for AI

Apply the first-principles safety and effectiveness confidence framework to AI-enabled medical products and AI-enabled development and manufacturing processes, with an emphasis on continuous assurance as technologies and use conditions evolve.

Challenges

Real-world challenges addressed

  • Evolving regulatory expectations
  • Model drift and changing performance
  • Bias and data representativeness
  • Human oversight and overreliance
  • Data quality
  • AI governance
  • Change control
  • Post-deployment monitoring
  • Responsible use of AI in regulated development and manufacturing activities

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