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Evaluating Artificial Intelligence in Medtech Regulatory Affairs

In today’s rapidly evolving regulatory landscape, medtech companies face increasingly complex challenges in bringing products to market while maintaining compliance.

As Artificial Intelligence (AI) gains traction across healthcare sectors, can generative AI truly help or replace regulatory experts?

This study compares six leading large language models (LLMs) to human expert performance on several regulatory tasks, ranging from tactical and discrete to broad and strategic.

AI vs. regulatory expert comparison includes:

  • Strategic Advice on the AI Act
  • Classifying medical devices
  • Retrieving and summarizing information

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