| |
Oct 23, 2026
|
|
|
|
|
BMED 2200 - Introduction to Medical Device Regulations and Ethics
Credits: 3
Catalog Description
This course introduces students to certification standards and the agencies involved in the regulatory processes specific to the medical device industry. Topics include FDA regulations, international regulations, quality certification processes, and related ethical considerations. Three lecture hours per week. BMED 1100 is strongly recommended as a first class for those with no previous biomedical device industry experience.
Additional fee to student: No
Learner Outcomes
- Understand the basic requirements of the FDA regulatory process for medical devices.
- Explain the regulatory submission requirements to regulating authorities in the USA, Canada, Australia, Europe, and Japan.
- Give examples of quality certification processes such as ISO 9000, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Lab Practices (GLP).
- Be able to discuss the ethical considerations involved in the formulation of and compliance with certification standards relating to the best quality of life outcome for the patient.
- Apply the course information to specific production and/or testing sites at local biomedical companies.
Major Areas of Course Content
- FDA regulations and medical device amendments
- International regulations: Europe, Canada, Japan, Australia
- Device classification
- Overview of Good Manufacturing Processes (GMP)
- Overview of Good Clinical Processes (GCP)
- Overview of Good Lab Processes (GLP)
- Ethical considerations in medical device testing
Credit for Prior Learning Options
No credit for prior learning option is available for this course.
Add to Portfolio (opens a new window)
|
|
