■ = classroom O = online ▲ = hybrid ☐ = both online and classroom sections available
Required Courses
Units
Course
Fall
Winter
Spring
Summer
Introduction to Medical Device Regulation
1.5
30058
■
■
Medical Device Quality Systems
2.5
30087
■
■
Design Control for Medical Devices
2.0
21973
■
Risk Management for Regulated Industries
3.0
22631
■
■
Human Factors and Usability in Medical Device Development
2.0
23097
■
■
■ = classroom O = online ▲ = hybrid ☐ = both online and classroom sections available
Elective Courses
Units
Course
Fall
Winter
Spring
Summer
Mobile Medical Applications
0.5
30045
■
■
Medical Device Verification and Validation
1.5
30042
■
Product Development Life Cycle for Medical Devices
2.0
23084
Post-Market Regulatory Obligations for Medical Devices
1.5
22414
■
Electronic Records for Regulated Environments: Cost-Effective Approaches to Compliance
1.5
19362
■
■
Regulation of Biomedical Product Advertising, Promotion and Labeling
1.5
20756
■
Value-Added Quality Audits
1.5
19073
■
Free Events
Units
Course
Fall
Winter
Spring
Summer
Clinical Trials, Regulatory Affairs, and Medical Devices Program Presentation
16650
■
■
Note: Individual courses may be taken without enrolling in the full certificate. Course schedule is subject to change, but reflects the current quarter and the anticipated schedule for the next three quarters. Check individual course descriptions for the latest scheduling information.