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Comment Showing 9 courses.

Syllabus Library Detail View
Course Quarter Units Fall Winter Spring Summer
Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements 2.5 +
Good Manufacturing Practices 3.0
Communicating and Negotiating with the FDA 1.5
Post-Market Regulatory Obligations for Medical Devices 1.5
Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment 2.0
Regulatory Submissions: Devices and Diagnostics 2.5
Global Medical Device Submissions and Strategy 1.5
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0
Design Control for Medical Devices 2.0 Spring TBD