Dec 08, 2025  
2024-2025 Undergraduate Catalog 
    
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2024-2025 Undergraduate Catalog [ARCHIVED CATALOG]

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ENCH 657 - Devices & Combination Products (3)

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 discussed 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.
 

Grading: Graded/Satisfactory Unsatisfactory/Audit
Course ID: 102818
Consent: No Special Consent Required
Components: Lecture


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