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Medical and combination device manufacturers face unique challenges when it comes to design. They must demonstrate to the FDA that they have followed a human factors engineering process during product development that identifies and mitigates use errors, in order to better ensure the safety of users and patients.

Usable Solutions brings extensive experience conducting the range of activities needed to implement FDA human factors guidelines & standards.

We help you consider the user, intended use, use environment, and user-interface for the whole package….your displays, controls, packaging, labeling, instructional materials, and training.


We work with software firms, pharmaceutical, and medical device manufacturers to identify, evaluate, and address use-related hazards 

The benefits?  Safety, user satisfaction, and increased confidence for your FDA submissions.


Services & deliverables include:

  • Use-related hazard analysis

  • User profiles

  • UI specification

  • Formative testing

  • Validation (Summative) testing

  • Root cause analysis

  • The Human Factors Engineering Report

  • And more…


Confidently navigate the FDA human factors roadmap...

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