Jan 02, 2025  
2022-2023 UMass Dartmouth Undergraduate Catalog 
    
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2022-2023 UMass Dartmouth Undergraduate Catalog [Archived Catalog]

BNG 428 - Medical Device Regulations & Regulatory Strategies

Credits 3
Lecture
Requirements: Prerequisite: BNG 255 or permission of instructorBNG 428
Discussion of the laws and regulations applied to medical products development, manufacturing, testing, marketing, and post-marketing surveillance. This course provides an overview of regulatory affairs related to biomedical devices and a foundation to understand the differences in regulations between countries with a focus on the US FDA requirements. This course also teaches risk management about medical products. Cross-listed with BNG 528
Graded