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  • Digital health and AI
  • Clinical evidence
  • Regulatory

Designing and delivering the clinical validation study for Medwise, an AI clinical search engine

What we did:

  • Developed a study protocol to meet regulatory requirements for a UKCA Class I submission.

  • Completed at scale human-in-the-loop analytical validation using a synthetically generated Q&A question bank.

  • Conducted a clinical validation study with 30 primary care physicians.

Impact:

  • Robust, regulator-ready evidence to meet UKCA Class I standards.

  • Comprehensive end-to-end evaluation report to support regulatory submission.

Funded by x2 successful Innovate UK grants.

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