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Medical Device Development - The Basics
Introduction to Medical Device Development - Academia vs. Industry
Introduction to Medical Device Development (13:51)
1. Project Management for Medical Devices - How Corporations Manage Projects
Project Management (10:01)
Project Lifecycle and Initiation (15:55)
Project Planning (18:32)
Project Executing, Control, and Closing (10:54)
Quiz 1
2. Pre-clinical Device development - Research Projects
Pre-Clinical Research Projects (17:39)
Managing in vivo Studies (18:18)
3. Regulatory Basics for Medical Devices
Regulatory Considerations and FDA (14:05)
Regulation of Medical Devices in the USA (21:09)
Role of The Regulatory Department (13:30)
Quiz 2
4. Quality Control and Quality Assurance
Quality Control and Quality Assurance (15:58)
The Quality System (15:58)
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