018: Larry Mager | Quality Systems Management

What is going on in the medical device industry right now that is driving companies and the FDA to address quality systems differently? What is the Quality Systems Management (QSM) Strategic Plan? How will it help organizations? How will it help patients? Larry Mager is an experienced medical device quality executive with success in taking quality management systems to the next level at major global medical device companies. He now is leveraging his decades of leadership and making his system available for any organization that wants or needs to improve. Quality System(s) Management (QSM) = Measure | Manage | Improve 1. A Quality System(s) Management (QSM) plan is utilized to measure, manage, and improve the 'quality' of an organization's Quality Management System (QMS) 2. QSM measures what matters in regard to product and process quality, and does so in a manner that is actionable for Management 3. QSM enables the strategic understanding of product & process 'quality', as is expected of Management by the stakeholders 4. QSM targets issues of constraint, enabling the responsible and targeted improvement of the organization's constraints 5. Supports EU MDR and Case for Quality initiatives (see below) EU MDR defines significant responsibilities associated with the verification of product & process 'quality' through the PMS & QMS surveillance activities utilized within a medical device company. The accountability for doing so resides within the designated role of Person Responsible for Regulatory Compliance (PRRC). The capability to satisfy the obligations of that role must be 'built' into the Quality Management System (QMS). The Case for Quality is an FDA-driven initiative, coordinated in partnership with the Medical Device Innovation Consortium (MDIC) and in collaboration with the Medical Device Industry, focused on creating "sustained predictive practices that advance medical device quality and safety." To connect with Larry: [email protected]