Slower roll-out of UDI System

FDA’s unique device identification (UDI) system, established in 2013 as a means to identify and track devices through distribution and use, is taking some time for implementation. The UDI system was expected to be implemented in stages over a seven-year period to...

Designing with attention to Human Factors…

While safety and efficacy is a predominate reason for using human factors tools in medical device design, a recent article in MDTmag written by Daniel Jenkins and Paul Draper, brings up the point that “Human Factors is not simply a tool for regulatory compliance”...