| 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, aseptic processes, clean-room techniques,, sterilization processes, clinical testing, lot traceability, introduction to automation and control systems, testing and instrumentation lab and manufacturing controls. (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 2300 Introduction to Quality Assurance,
3 credits
This course will provide students with an in-depth understanding of the role quality plays in an industrial environment regulated by the Food and Drug Administration (FDA). The course will cover the responsibilities of quality assurance during the engineering, manufacturing, and production of a product. Topics will include management responsibilities, design control, production and process controls, continuous improvement, and methods and tools used to support quality assurance. The ISO standards, the regulatory requirements mandated by the FDA, and the European Medical Devices Directive (MDD), are also covered.
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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