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.

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

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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 

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

 

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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…