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Oct 23, 2026
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BMED 2320 - Quality Management for Medical Devices
Credits: 3
Catalog Description
This course defines the role of quality also referred to as performance excellence in a business environment, as it is applied within the Medical Device industry in relation to ISO 13485 and FDA Quality System Regulations. Topics include the use of quality management techniques and quality philosophies, organization and process development for quality, techniques used in process design and improvement, approaches used in continuous improvement, methods used to control quality. The course includes organizational design and leadership concepts in achieving quality services and products.
Recommended Skills, Abilities, or Coursework: BMED 2300
Additional fee to student: No
Learner Outcomes
- Explain how quality management affects an organization’s effectiveness, efficiency, market competitiveness and its impact on its customers.
- Compare business models that other high performance companies use to achieve performance excellence.
- Demonstrate familiarity with the concepts of quality and how it becomes a cultural way of business thinking.
- Discuss various tools and techniques of quality management within the construct of the process design/ improvement team.
- Illustrate how teamwork and a highly empowered workforce is necessary for quality work.
- Support the essential role of leadership in the transformational process of achieving a performance excellence business.
Major Areas of Course Content
- Introduction to quality and performance excellence
- Frameworks for organizational quality
- Performance excellence, competitive advantage and strategic management
- Quality in customer-supplier relationships
- Designing organizations for performance excellence
- Designing, controlling and improving organizational processes
- Tools and techniques for performance excellence
- Quality teamwork
- Engagement, empowerment and motivation
- Leadership for performance excellence
- Performance excellence and organizational change
- Review of the Malcolm Baldridge Award Criteria, Florida State Sterling Award and ISO 9000 Standard
Credit for Prior Learning Options
No credit for prior learning option is available for this course.
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