| This chart outlines the certificate curriculum (pending academic approval, excepted for the summer 2012). Click here to read course details and enroll. | ||||||
| ■ = classroom O = online ▲ = hybrid ☐ = both online and classroom sections available |
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| 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 |
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| 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 | ■ | |||
| Compliance with 21 CFR Part II: Electronic Record Signatures and Software Validation | 1.5 | 19362 | ■ | ■ | ||
| Value-Added Quality Audits | 1.5 | 19073 | ■ | |||
| New! Data Privacy and Security for Healthcare and Biosciences | 1.5 | 30120 | ■ | ■ | ||
| New! Medical Device Marketing | 3.0 | 30119 | ■ | ■ | ||
| Free Events | Units | Course | Fall | Winter | Spring | Summer |
|---|---|---|---|---|---|---|
| Clinical Trials, Regulatory Affairs, and Medical Devices Program Presentation | 16650 | ■ | ■ | |||
| Bioscience Program Information and Q&A Session | 22402 | ■ | ■ |
Note: Any one course from UCSC Extension's Regulatory Affairs Certificate Program may be applied toward the elective unit requirement for the Medical Devices Certificate.
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.