BME 5510

Last Updated

  • Schedule of Classes - June 11, 2025 2:48PM EDT

BME 5510
Medical Device Regulatory Affairs for Biomedical Engineers

Course information provided by the 2025-2026 Catalog.

This course is designed to provide a working knowledge of Medical Device Regulatory Affairs specifically for Biomedical Engineers. It is geared for both experienced biomedical engineering professionals as well as those new to the industry and is intended for non-regulatory professionals who need a better understanding of the regulatory requirements necessary to bring medical devices to market. This course demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialties. Strategies for using regulation as a competitive advantage will also be discussed. Instructor will be lecturing virtually (on-line) but in real-time.


Enrollment Information REF-F25 Enrollment limited to: M.Eng students.

Last 3 terms offered 2024FA, 2023FA, 2022FA

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Syllabi: none

  •   Regular Academic Session. 

  • 2 Credits Stdnt Opt

  •  5196 BME 5510   LEC 001

    • M
    • Aug 25 - Dec 8, 2025

    • Drues, M

  • Instruction Mode: In Person

    Department Consent Required (Add)