What we do

Aligning human factors activities with your risk management plan and regulatory strategy from the outset ensures a streamlined process and helps avoid regulatory pitfalls. 

Conducting early-stage exploratory user research uncovers unmet user needs and specifications, forming the foundation for many of your design inputs and design decisions.

By leveraging a variety of research tools and methodologies, from task analysis to use-related risk assessments, we can detect known or potential use problems early, guiding the direction of device development. 

Collaborating with the design team, a human factors specialist provides continual user feedback through iterative usability tests, heuristic evaluations, and expert reviews, offering meaningful real-world data to the designers. 

 Validation testing is a regulatory requirement to demonstrate that the device is safe and effective. A robust human factors process determines the complexity of testing needed and ensures the data is accepted by the regulatory authority. 

The human factors regulatory submission should be tailored to guide the reviewer effortlessly through the process, presenting only the critical and relevant data to avoid overwhelming or distracting them.