The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite

Kim Trautman, who authored the Quality System Regulation in the 1990s, says US FDA officials tasked with retooling the QSR will have to consider an array of other device-related rules that address complaints, product recalls and traceability – just to name a few – to make sure those requirements will still be met by manufacturers.