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USABILITY EVALUATION

Usability evaluations that deliver, from design insights to submission evidence.

Usability evaluation ensures that medical devices can be used safely, effectively, and intuitively by their intended users. Beyond supporting regulatory submissions, usability evaluation provides actionable insights that inform and improve design at every stage of development.

Usable Solutions evaluation methods include:

  • Formative Usability Testing – uncover strengths & issues along the way to guide design

  • Summative Usability Validation – demonstrate safe & effective use for regulatory submissions

  • Benchmark Usability Testing – compare performance against prior or competitor products

  • Expert Reviews – supplement testing by identifying potential usability issues early

  • Cognitive Walkthroughs – simulate user problem-solving to evaluate task flow

  • Heuristic Analysis – assess designs against established usability principles

By applying the right evaluation methods at the right time, Usable Solutions helps you reduce use-related risk, strengthen your design decisions, and generate usability evidence regulators expect.

Ready to get started?

Wherever you are in development, we’ll help you deliver safer, more intuitive devices and stronger submissions. Contact us to learn more.

(603) 537-0102

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© 2025 by Usable Solutions, LLC

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