BCG March 18, 2025
Meghna Eichelberger, Gunnar Trommer, Steffen Simon, Miriam Fritsche, Chris Meier, Nigel Markey, Myrto Lee, and Kevin Dsouza

Key Takeaways

As the regulatory burden in medtech grows, a structured approach to using generative AI (GenAI) can provide dramatic gains in efficiency, accuracy, and other key metrics. Early adopters in the health care industry that deploy traditional and generative AI in quality management systems and regulatory affairs functions are gaining a real competitive advantage.

  • Pharmaceutical companies are already applying GenAI technology for regulatory and quality processes, generating first drafts for human review, reducing the variance...

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