Is the US FDA replacing its Quality System Regulation (QSR) with international quality systems standard ISO 13485? Perhaps. Sean Boyd of the FDA’s Center for Devices and Radiological Health has suggested as much at MedCon 2018. But it won’t be fast or easy. In fact, the QSR’s author, Kim Trautman, told Medtech Insight that it would take considerable time and “a lot–a lot of–work.” As global regulators seek ways to align–or even converge–various requirements, what are the implications for device makers? Learn what’s at stake and gain insights into just what’s required for FDA to make this enormous regulatory change.