|
|
|
Apr 19, 2024
|
|
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.
Add to Personal Catalog (opens a new window)
|
|
|
