Do you know the difference between quality management system (QMS) and quality systems management (QSM)? Today’s guest is Larry Mager of Mgmt-Ctrl. He describes the difference between QMS and QSM, as well as offers tips on concepts that make medical device businesses more efficient and effective to benefit patients. Some of the highlights of the show include: ● Challenges with management control include the different definitions of quality management. Most organizations define it too narrowly and passively. ● QMS documents processes, procedures, and responsibilities to achieve quality policies/objectives. ● For Mgmt-Ctrl, QMS includes quality operations and QSM. The QSM solution is designed to measure, manage, and improve the quality of products/processes. ● Companies focus more on compliance than quality due to costs. Predictive analytics extract info from data to find patterns that may predict outcomes. ● Company’s executive team and person responsible for regulatory compliance (PRRC) are responsible for measuring and confirming process/product quality. ● Medical device companies need to be proactive, not reactive. And, they need to understand management control terminology, such as product and process. ● Design and development process has not focused on critical quality controls or reviewed released products against those controls to make adjustments. ● A medical device that’s a software component must be controlled and managed appropriately within a quality system.