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