Scroll Top

Dialysis Clinic Monitor

Medical Device Human Factors + TRAINING

“Hach hired Sage to help them with the Human Factors component of their first-ever medical device submission to the FDA. While they had a great in-house UX team of skilled designers and researchers, the ins and outs of the Usability Engineering/Human Factors process described in the FDA guidance was new to them. We worked side-by-side with the internal teams to not only ensure a successful outcome, but to also train the team on Human Factors processes. The CM130 monitor has now been FDA-approved and Hach is boasting about its superior human-centric design.

  • HF Process Audit
  • Heuristic Evaluation
  • Use Specification Preparation
  • Formative Testing (2 rounds)
  • Summative Testing
  • Usability Engineering File (UEF) Preparation
  • Formative and Summative Testing Apprenticeship