Quality Management System Regulation – Management Responsibility

The change from QSR to QMSR represents the most significant regulatory shift in three decades in the medical device space. At the center of this evolution is Clause 5, outlining Management Responsibility. While the previous regulation required leadership oversight, the QMSR introduces a more rigorous, data-driven, and risk-centric expectation for top management. 

In this course, we’ll review these new expectations by following the QMSR transition at a fictional company. Learners will be given the opportunity to help the fictional CEO become more compliant with the new regulation.