Course List (10 courses, 30 units)
The Master of Science in Medical Device Engineering program at CSUN has designed a curriculum to provide students an opportunity to apply principles from engineering and other fields to design, test and analyze medical devices and treatments.
- ME 505: Medical Devices and Systems
- ME 506: Regulatory Affairs of Medical Devices
- ME 507: Human Factors in Medical Devices
- ME 508: Biotransport Phenomena
- MSE 536: Introduction to Advanced Biomaterials
- ME 510: Medical Device Manufacturing
- ME 605: Statistical Methods and Analysis of Medical Devices
- ME 606: Control of Medical Devices
- ME 692: Computational Fluid Dynamics
- ME 698C: Thesis or Graduate Project
Course Descriptions
| Course | Name | Units | Description |
|---|---|---|---|
| ME 505 | Medical Devices and Systems | 3 units | The graduate-level course provides a comprehensive introduction to active and passive devices for healthcare applications. Topics include medical implantable and wearable devices, and standards in the design and development of medical technology. |
| ME 506 | Regulatory Affairs of Medical Devices | 3 units | The United States Food and Drug Administration is responsible for the safety and efficacy of medical devices sold in the United States. This course will focus on Title 21 Subchapter H (Medical Devices) of the Code of Federal Regulations, in particular Part 820 (Quality System Regulation) which governs the design, development, manufacture and post-sale facets. Other parts relevant to Medical Device Design and Development such as Part 801 (Labeling) and Part 822 (Post Market Surveillance) will also be discussed. |
| ME 507 | Human Factors in Medical Devices | 3 units | This course will help understand human factors engineering processes for designing medical devices. Topics include design theory, risk and safety, and testing/standards/regulations used in the medical industry. |
| ME 508 | Biotransport Phenomena | 3 units | This course provides a comprehensive overview of medical device manufacturing processes and technologies. It will cover the essential manufacturing principles and regulations governing the medical product manufacturing process including quality assurance and control. |
| MSE 536 | Introduction to Advanced Biomaterials | 3 units | The interaction between the human body environment and synthetic materials, including materials for medical implants and for dental restoration and appliances is explored. Tissue engineering, biosensing, imaging and drug delivery interact directly with biomaterials. Consideration of new technologies that depend on overcoming present material limits, and improving material/biological environment interactions. |
| ME 510 | Medical Device Manufacturing | 3 units | This course provides a comprehensive overview of medical device manufacturing processes and technologies. It will cover the essential manufacturing principles and regulations governing the medical product manufacturing process including quality assurance and control. |
| ME 605 | Statistical Methods and Analysis of Medical Devices | 3 units | A comprehensive introduction to statistical techniques and their implementation in design and quality control of medical devices. Topics include design of experiments and response surface approximations and their implementation via statistical software. |
| ME 606 | Control of Medical Devices | 3 units | This course explores the principles and applications of control systems in designing and developing medical devices. Students will learn about integrating control theory, mechanical engineering, and biomedical engineering to create devices that improve healthcare delivery and patient outcomes. |
| ME 692 | Computational Fluid Dynamics | 3 units | This course provides an introduction to the numerical analysis of fluid flows. Special techniques required for solution of the governing equations for viscous, inviscid and boundary layer flows. Applications to convective heat and mass transfer. Turbulence modeling and other submodels for complex engineering applications. |
| ME 698C | Thesis or Graduate Project | 3 units | This course is the culminating experience for the Masters of Science in Medical Device Engineering program. |
