BTEC 657 - Devices and Combination Products

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This course is designed to provide students with comprehensive coverage of all aspects for the development and Life Cycle Management (LCM) of Combination Products (CP) and Devices. Subject areas discusses will include: routes of submissions of Devices and Combination Products such as NDA, BLA, MAA, 510(k). Scientific background for the development of Devices and CP. Clinical studies vs. Human Factors studies.
Course ID: 102711
Components: Lecture
Grading Method: R