Human Factor
Engineering

In-depth usability testing and validation built-in the design development process for FDA compliance.

Built-in compliance in the design process.

Trained directly by the Human Factor Engineering VP of WORRELL Minneapolis Serge Dubeau. I oversaw the Human Factor Engineering studies at Worrell Shanghai with a focus on improving the product's user experience and safety.

I did supervise the testing process from preliminary risk assessment to the staggered user tests in compliance with the latest regulation set by the FDA and IEC: 62366. 

Key Deliverables

→Task Analysis.
→Iterative Hazard Analysis.
→Testing Training IFU.
→Preliminary usability testing protocol & report.
→Formative usability testing protocol & report.
→Summative usability testing protocol & report.
→Design recommendation report.