Usability Engineering and

Human Factors


Assessments and audits of Usability Engineering process

Remediation planning and full service retrospective usability evaluations

Human Factors Validation Testing

Formative and Summative Simulated-Use Evaluations

Usability Safety Risk Analysis assessment and review

Use/User Interface Specifications assessment and review

User-centered Design Tools and Processes

FDA Compliance and Usability Information for premarket submissions

IEC 62366 Conformance

Ensuring Device USE
(“Usability built on Safety and Effectiveness”)

Efficient Usability Processes for Low Risk Devices

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  Customized to your needs

  Risk-based approach

  Planning, review, or outsourcing


Human Factors Validation (Summative) Study – Our staff can provide an independent, comprehensive review of the safety and effectiveness of the use of your device to include with your submission.  We can plan, execute, and document an FDA-compliant simulated-use study. Tasks included in the study protocol will be based on an assessment of device use-related hazards and primary operating functions.  Study participants will be recruited based on characteristics of identified user groups and results will include the number of occurrences and root cause analysis of the observed use errors and near misses.


Formative Evaluations – Whether you are developing an entirely new interface or adding a feature to an existing interface, our staff can work with you to determine if one or more formative evaluations are needed and what areas of the user interface should be targeted.  Formative evaluations can range from quick and informal to “pre-validation like” and provide design guidance on anywhere from a single feature to the overall user interface.


Usability Risk Analysis assessment and review – From the perspective of the FDA and the new IEC 62366-1, a summative usability study must demonstrate safe and effective use of the device. Do you understand what use errors could result and have you effectively mitigated those errors?  Have you identified the areas of the user interface where the user is required to take action to manage the risk of certain hazards (and if they can/will do so effectively)?  Our staff can assist you with answering these questions.


Human Factors regulatory submission documentation (and NB required documentation) – Usability specifications, user interface specifications, usability risk analysis, and adequate usability engineering file documentation are needed to satisfy IEC 62366 and are required for adequate software validation.


Bridging Usability to System/Device Risk Management-

The ultimate value of usability engineering happens when it is related to the overall picture of risk management for the device, and this is the regulatory expectation - the described structure of the standards -ISO 14971 and IEC 62366 make this clear.  Our extensive risk analysis experience with many kinds of devices helps us analyze, understand, and describe how the usability aspects of your device demonstrate effective safety risk management.  We can link and integrate usability information with system risk analysis, no matter what methodology may have been used.


User-Centered Design Tools and Processes – From performing contextual inquires, user needs analysis, usability risk analysis, individual interviews, focus groups, functional and task analyzes, heuristic and expert reviews, as well as formative and summative studies, our staff has the tool set to assist you in development of a highly usable product that effectively manages safety risk while offering the features demanded by the market.


Submission Support - An HFE/UE report is needed for your FDA submission.  Our staff can assist you in streamlining the usability engineering process and providing the necessary documentation to satisfy both.


Process documents – We can help you create the necessary plans and standard operating procedures that are essential for IEC 62366 compliance.


Are you facing Notified Body assessment audit issues related to 60601-1, 3rd Edition because of the lack of usability documentation? We can help with retrospective evaluation and efficient approaches to compliance for legacy products.