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Apr 25, 2024
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MEDDV 101 - Introduction To Quality Assurance
3.0 Credits Understand the role quality plays in an industrial environment regulated by FDA. Topics: responsibilities of QA during engineering, manufacturing, production process; management responsibilities, design, production, process controls, continuous improvement/ quality assurance. Course-level Learning Objectives (CLOs) Upon successful completion of this course, students will be able to:
- Demonstrate an understanding of the role quality assurance plays in ensuring that medical devices meet FDA compliance regulations for manufacturing in the FDA regulated market.
- Identify and discuss quality concepts and applications in medical devices during the engineering and manufacturing process.
- Review and identify methods for medical device design control, production/process control, and continuous improvement.
- Describe the ISO standards, the FDA regulatory environment and the European Medical Devices Directive.
- Outline management responsibilities as they relate to the QA process.
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