3 credits
Summer 2025 Distance Learning Lecture Upper Division
Medical devices are developed and manufactured in a highly regulated environment. This course will provide an introduction, overview, and systematic study of the intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices. Focus is on understanding the critical elements of regulatory science and quality compliance from a design control perspective. Instruction and mentoring in regulatory science skills is provided by academics and industry representatives with expertise in their fields. This course is part of a three-course series.
Learning Outcomes1Demonstrate a functional understanding of regulatory compliance for biomedical devices.
2Use the main tools within the quality craft (Ex: confidence interval, control chart, difference between a T-test and F-test).
3Demonstrate understanding of how the FDA approaches control.
Restrictions
made by Purdue students.