| BMED 1100 Introduction to Biomedical
Devices and Industry, 2 credits
This course gives the student a general understanding of the biomedical device industry in terms of its size and scope, current trends, and the wide range of products involved with emphasis on biomedical companies in Minnesota. The course will also give the student an overview of the development of a medical device from initial conception through development, testing, validation, manufacture, clinical trials and final approval by regulatory agencies. Two lecture hours per week plus two Saturday field trips. BMED 1100 is strongly recommended as a first class for those with no previous biomedical device industry experience.
BMED 2100 Design and Manufacturing in the
Medical Device Industry, 3 credits
This course provides an introduction to the design and manufacturing of medical devices with special focus on the unique design manufacturing challenges that are necessary to achieve World Class Manufacturing (WCM) excellence. The course describes the fundamental systems used in the design, development and manufacturing of medical devices and how these relate to industry regulations. Specific topics include material and process selection considerations, clean rooms, sterilization processes, clinical testing, lot trace ability, and manufacturing controls. Three lecture hours per week. BMED 1100 is strongly recommended as a first class for those with no previous biomedical device industry experience.
BMED 2200 Introduction to Medical Device
Regulations/Ethics, 3 credits
This course introduces students to certification standards and the agencies involved in the regulatory processes specific to the medical industry. Topics include FDA regulations, international regulations, quality certification processes, and related ethical considerations. Three lecture hours per week. BMED 1100 is strongly recommended as a first class for those with no previous biomedical device industry experience.
BMED 2297 Field Experience and Seminar,
4 credits
Prerequisite: Permission of the program director.
Provides a supervised practical, industry-based learning experience in a setting consistent with the student’s biomedical career goals in which the student develops professional skills through work experience.
BMED 2400 Introduction to Clinical Research,
3 credits
Prerequisite: MATH 1110, or equivalent, or concurrent enrollment.
This course will provide the foundation for understanding the research process and its application to clinical trials in the biomedical industry. Topics include the role of the clinical research professional, the process of designing, implementing, managing and reporting a clinical study, and ethical issues related to clinical research. Three lecture hours per week.
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