Last week I published IEC 62366-1:2015 – More Than A Checkbox on the Human Factors MD website.
The post provides a brief overview of the medical device usability standard, the importance of a Usability Engineering Process, and how it better aligns with the FDA Draft Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
A big thanks to my colleagues Tim Reeves, PhD, CHFP and Christina Mendat, PhD for their input and insights.
Leave a Reply