Human factors offerings

By taking a holistic approach to human factors testing, we are able to understand the product, it’s users and their needs, and the conditions under which the users will be interacting with the device.

PRELIMINARY ANALYSIS

Focusing on the user interface during early stages of product development, our team works with you to design an optimized user experience that sets the stage for safe and effective use.

Formative Testing

Executing formative testing early in the product lifecycle allows us to identify improvement areas for design that reduce user error, inform risk mitigation strategies and help to develop an outstanding product overall.

Understand the product and its intended use
Identify user characteristics (capabilities and limitations)
Complete preliminary use risk assessment to identify critical tasks
Develop realistic use-scenarios
Conduct preliminary product testing consistent with standards and guidance (FDA, IEC, AAMI, ISO)
Provide Findings in formal usability reports
Summative Testing

Through summative testing and human factors validation, users demonstrate they can interact with the device as intended in realistic conditions without serious use errors proving the product is ready for submission.

Pinpoint critical tasks and success criteria
Refine realistic scenarios to evaluate all critical tasks
Test actual/intended users with representative product
Establish that the product is safe, effective and meets validation criteria
Report Findings in formal usability reports and final Usability Engineering File Summary
Ensure compliance with relevant standards and guidelines (FDA, IEC, AAMI, ISO)
UEG approach to human factors Research

When it comes to healthcare and clinical products, making the right call becomes even more critical. Not only is the product’s success on the line, but so are people’s lives. At UEGroup, we have experience across a variety of research techniques and provide human factors expertise throughout the product lifecycle. Whether it’s use risk assessments, formative and summative usability testing or authoring reports for inclusion in FDA submissions, we’re here to help you succeed.

UEGroup is a one stop shop for the medical research process and your product’s needs. We understand the complexity of applying Human Factors processes and create a customized strategy for your product that is actionable, mitigates risk and complies with standards and guidelines at every step. Being proactive by testing early and often results in safe, effective products and avoids costly design changes late in the game.

Since we specialize in preliminary analysis, formative and summative testing, the path to FDA approval is streamlined; managed by one team bringing a comprehensive view to your product’s compliance. UEGroup’s experienced team will be with you throughout the product development and validation process, providing guidance and implementing best practices.

MEET SOME OF OUR RESEARCHERS
We’re curious by nature and we’re good at it. We know how to break down findings so they are meaningful to you. UEGroup researchers are a fun, close-knit team who like rolling up their sleeves and getting their hands dirty.
MEET THE REST OF OUR TEAM
SARAH 
GARCIA
Sleuth
INGRID 
MASSON-CARRO
Mind Hunter
MEGAN 
MCCRACKEN
Cognitive Genie
FDA
Applying Human Factors and Usability Engineering to Medical Devices
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ISO 13485
Medical devices – Quality management systems – Requirements for regulatory purposes
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ANSI/AAMi HE75:2009
Human factors engineering - Design of medical devices
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IEC 62366
Medical Devices - Application of usability engineering to medical devices
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