Steve GompertzMar 15, 20223 minProblem Definition: The Three Most Common MistakesWritten by: Steve Gompertz, Partner, COO During a presentation the other day on steps for effective Root Cause Analysis (RCA), attendees...
jackietorfinAuditing, the Often-Thankless Taskby Steve Gompertz, QRx Partners Performing audits is great way to increase your understanding of quality management system requirements...
jackietorfinChange is Hard. Why Progressive Improvement BEATS Postponed Perfection.Written by Jackie Torfin, Partner I "DO" change leadership. I am a proud change agent. I have led many change initiatives, from Quality...
jackietorfinThe Long and Winding Road - Shortcuts to FDA Market Authorizationby Mark Swanson and Steve Gompertz, QRx Partners While most medical devices are required to follow the 510(k) and PMA pathways, the FDA...