BMED 1100 -- Introduction to Biomedical Devices and Industry, 2 credits Common Course Outline 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 Common Course Outline 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 and Ethics, 3 credits Common Course Outline This course introduces students to certification standards and the agencies involved in the regulatory processes specific to the medical device 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 -- Capstone Experience and Seminar, 4 credits Common Course Outline Prerequisite: Permission of Program DirectorRecommended Skills, Abilities, or Coursework: BMED 1100, BMED 2100, BMED 2200This course provides a supervised, practical, industry-based learning experience in a setting consistent with the student's program goals in which the student develops professional skills through work experience. Students are expected to complete a Technical Skills Assessment of the instructor's choice prior to completion of this course. BMED 2300 -- Introduction to Quality Assurance, 3 credits Common Course Outline 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 2310 -- Risk Management and Assessment for Medical Devices, 3 credits Common Course Outline Recommended Skills, Abilities, or Coursework: BMED 2300This course provides the students with an in-depth understanding of the principles and techniques of identifying, evaluating, and controlling risks associated with the development and production of medical devices. This course will cover risk management planning, risk analysis process, and risk management reporting. Topics will include the relationship between regulatory requirements and risk management, tools for hazard identification, methods for the mitigation of risks, and approaches for analyzing risk verses benefit. BMED 2320 -- Quality Management for Medical Devices, 3 credits Common Course Outline Recommended Skills, Abilities, or Coursework: BMED 2300This course defines the role of quality also referred to as performance excellence in a business environment, as it is applied within the Medical Device industry in relation to ISO 13485 and FDA Quality System Regulations. Topics include the use of quality management techniques and quality philosophies, organization and process development for quality, techniques used in process design and improvement, approaches used in continuous improvement, methods used to control quality. The course includes organizational design and leadership concepts in achieving quality services and products. BMED 2400 -- Introduction to Clinical Research, 3 credits Common Course Outline Prerequisite: MATH 1114 with a grade of C or better or concurrent enrollmentThis 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. BMED 2500 -- Introduction to Documentation/Configuration Management, 3 credits Common Course Outline Recommended Skills, Abilities, or Coursework: BMED 2200This course is geared towards individuals and/or teams interested in establishing and managing documentation and related systems in the area of medical device manufacturing. The curriculum introduces students to the fundamentals of governmental requirements that impact medical device documentation, the benefits and elements of a documented configuration management system, and the details to establish related systems, policies, procedures and tools. BMED 2510 -- Database Management for the Medical Device Industry, 3 credits Common Course Outline Prerequisites: BUS 1119 with a grade of C or betterThis course is designed for all those interested in an interesting, well-compensated career path. Database management is an interesting field with responsibilities for organizing data from many sources, assuring data integrity, and helping to design systems and software to run on those systems. This course is an opportunity for anyone working in the medical device industry to learn the opportunities and challenges offered by Database Management. The course covers relational databases, programming languages, life cycles, validation, compliance, security, backup and archive, ethics and privacy, regulations and regulators. Coursework includes database model comparisons, vendor demonstrations, setting up your own company's validation procedures, security model, and code of ethics. BMED 2520 -- Technical Writing for Regulated Industries, 3 credits Common Course Outline Prerequisites: ENGL 0950 with a grade of C or better or achievement of required score on English placement assessmentThis course will provide instruction in the rhetorical principles and strategies of technical writing as they apply to documentation in regulated industries. The course will emphasize technical writing for documents used in regulatory-compliant electronic or hybrid systems. BMED 2600 -- Fundamentals of Dimensional Metrology, 2 credits Common Course Outline All things manufactured need to be measured. Metrology is the science of measurement and is used to determine if a part meets its required form, fit or function. This course is designed to train students on metrology equipment used in industry to measure the physical size or distance from any given object. Both English (inch) and Metric (cm) systems of measurement will be used in measuring practices. Completing this course will enhance the learner's ability to gain employment in a manufacturing/machining/medical facility area and/or increase their chances of advancement in Quality Assurance related roles.
