MSc Medical Devices – Curriculum and Courses
March 20, 2026 2026-03-20 18:10MSc Medical Devices – Curriculum and Courses
MSc in Medical Devices, Regulatory Affairs & Health Information Technologies — Curriculum & Courses
Aleph University’s Master of Science in Medical Devices, Regulatory Affairs, and Health Information Technologies is a 30-credit professional degree designed for healthcare professionals, engineers, and regulatory specialists seeking advanced expertise in the medical technology sector. The program offers three flexible concentration tracks—Medical Devices, Regulatory Affairs & Quality Assurance, and Health Information Technologies—allowing students to tailor their education to their career goals and industry interests.
Core Courses (Required)
All students complete the following core curriculum regardless of concentration track selection. These foundational courses provide essential knowledge in ethics, leadership, biomedical sciences, and professional development.
| Course Code | Course Title | Credits | Prerequisites |
|---|---|---|---|
| HUM 500 | Ethics and Values Seminar | 2 credits | None |
| HUM 510 | Leadership, Teamwork and Success Principles Seminar | 2 credits | None |
| BME 601 | Medical Sciences | 3 credits | None |
| BME 610 | Medical Physics | 3 credits | Prereq: BME 601 |
| BME 611 | Medical Devices | 3 credits | Prereq: BME 601 |
| BME 700 | Special Topics Seminar | 2 credits | Prereq: BME 601 |
| BME 710/720 | Internship or Capstone Project | 3 credits | Prereq: ENT 510 |
| ENT 621 | Innovation and Entrepreneurship | 2 credits | Prereq: BME 611 |
Concentration Tracks
Students select one of three concentration tracks and complete two electives within their chosen specialization. This focused pathway allows deep expertise development in your area of professional interest.
Medical Devices Track
Select 2 electives (4 credits minimum)
| Course Code | Course Title | Credits | Prerequisites |
|---|---|---|---|
| BME 530 | Biomedical Instrumentation | 2 credits | Prereq: BME 611 |
| BME 540 | Biomedical Signal Analysis | 2 credits | Prereq: BME 530 |
| BME 630 | Engineering Compliance | 2 credits | Prereq: BME 530, ENT 621 |
| BME 619 | Clinical Engineering and Technology Management | 2 credits | Prereq: BME 530 |
Regulatory Affairs & Quality Assurance Track
Select 2 electives (4 credits minimum)
| Course Code | Course Title | Credits | Prerequisites |
|---|---|---|---|
| RAQ 520 | Quality Management Systems | 2 credits | None |
| RAQ 532 | Product Safety and Performance Testing | 2 credits | Prereq: RAQ 520 |
| BME 611 | Medical Device Regulations | 2 credits | Prereq: RAQ 520 |
Health Information Technologies Track
Select 2 electives (4 credits minimum)
| Course Code | Course Title | Credits | Prerequisites |
|---|---|---|---|
| BME 620 | Medical Imaging Systems | 2 credits | Prereq: BME 610 |
| BME 625 | Diagnostic Ultrasound Instrumentation | 2 credits | Prereq: BME 620 |
| BME 621 | Health Information Technologies | 2 credits | Prereq: BME 620 |
| HIM 622 | Medical Informatics, Telemedicine and E-Health | 2 credits | Prereq: BME 620 |
| BME 627 | Science and Technologies in Healthcare | 2 credits | Prereq: RAQ 520 |
Detailed Course Descriptions
Core Courses
HUM 500 — Ethics and Values Seminar (2 credits)
This seminar explores ethical frameworks and decision-making principles essential to healthcare leadership. Students examine real-world case studies involving ethical dilemmas in medical device development, regulatory compliance, and organizational culture. The course emphasizes values-based leadership and the role of sustainability and social responsibility in healthcare innovation.
HUM 510 — Leadership, Teamwork and Success Principles Seminar (2 credits)
Designed for healthcare professionals and biomedical engineers, this course develops essential leadership competencies including team dynamics, conflict resolution, and strategic goal-setting. Students learn project management methodologies and how to lead cross-functional teams in complex healthcare environments, preparing them for management roles in medical device companies and healthcare organizations.
BME 601 — Medical Sciences (3 credits)
A comprehensive overview of human anatomy and physiology relevant to medical technology, covering the cardiovascular, respiratory, digestive, and nervous systems. The course includes clinical case studies demonstrating how physiological understanding informs device design and therapeutic approaches, providing essential context for all subsequent biomedical engineering courses.
BME 610 — Medical Physics (3 credits)
This course covers the physics principles underlying medical applications including radiation physics, medical imaging (CT, MRI, PET), and radiation therapy. Students explore biomedical instrumentation fundamentals and the physical principles governing diagnostic and therapeutic medical devices, essential for professionals working in imaging and radiation-based technologies.
BME 611 — Medical Devices (3 credits)
An in-depth study of diagnostic and therapeutic medical devices spanning electrophysiology, medical imaging, implantable devices, and clinical equipment. The course examines device design principles, clinical applications, safety considerations, and regulatory pathways, providing comprehensive knowledge of the medical device landscape for all concentration tracks.
BME 700 — Special Topics Seminar (2 credits)
This elective seminar addresses contemporary and specialized topics in biomedical engineering through faculty-led instruction and expert guest lectures. Students engage in research projects and critical thinking exercises on emerging technologies, innovative applications, and current industry challenges, promoting professional development and cutting-edge knowledge.
BME 710 — Internship (3 credits)
Students gain supervised, hands-on experience in medical device companies, regulatory agencies, or healthcare facilities. The internship develops practical professional skills, industry knowledge, and professional networking while allowing students to apply classroom learning to real-world challenges in their chosen specialization.
BME 720 — Capstone Project (3 credits)
A comprehensive capstone project centered on a real-world biomedical engineering case study, often developed in collaboration with industry partners. Students demonstrate mastery of program competencies through rigorous analysis, solution design, and professional presentation of their findings to faculty and industry stakeholders.
ENT 621 — Innovation and Entrepreneurship (2 credits)
This course cultivates entrepreneurial thinking and innovation capabilities essential for advancing medical technologies. Topics include creativity and ideation techniques, market research, business planning, intellectual property protection, and entrepreneurial leadership, preparing students to launch ventures or lead innovation initiatives within established organizations.
Medical Devices Track Electives
BME 530 — Biomedical Instrumentation (2 credits)
Students learn the design and operation of essential biomedical instruments including electrocardiography (ECG), electromyography (EMG), blood pressure monitoring, and respiratory instrumentation. The course covers sensor technologies, signal conditioning, safety standards, and practical applications in clinical settings, providing foundation for advanced signal analysis and device design.
BME 540 — Biomedical Signal Analysis (2 credits)
Advanced course in signal processing techniques for biomedical applications including ECG, EEG, and EMG analysis. Students develop algorithms for feature extraction, pattern recognition, and clinical interpretation while exploring real-world applications in diagnostics and patient monitoring, essential skills for medical device software development.
BME 630 — Engineering Compliance (2 credits)
Focuses on regulatory compliance strategies for medical devices throughout their lifecycle. Topics include design control, risk management, safety and data privacy regulations, FDA and international compliance standards, and audit procedures. Students learn how to integrate compliance into engineering processes from conception through commercialization.
BME 619 — Clinical Engineering and Technology Management (2 credits)
This course examines medical technology lifecycle management from planning and procurement through clinical deployment, maintenance, and eventual retirement. Students learn healthcare facility operations, technology assessment, cost-benefit analysis, and best practices for managing biomedical equipment in clinical environments.
Regulatory Affairs & Quality Assurance Track Electives
RAQ 520 — Quality Management Systems (2 credits)
Comprehensive study of Quality Management System (QMS) components, standards, and implementation. The course covers ISO 9001 standards, FDA Good Manufacturing Practice (GMP) requirements, continuous improvement methodologies, and compliance auditing. Essential for professionals responsible for quality assurance and regulatory operations in medical device organizations.
RAQ 532 — Product Safety and Performance Testing (2 credits)
Detailed examination of safety and performance testing methodologies including in vitro testing, animal testing, human factors analysis, and bench testing approaches. Students learn regulatory guidelines, test protocols, documentation requirements, and how testing data supports regulatory submissions and device approvals in various jurisdictions.
BME 611 — Medical Device Regulations (2 credits)
In-depth exploration of regulatory frameworks governing medical device development, approval, and commercialization. The course covers FDA regulatory pathways, international regulatory requirements, post-market surveillance obligations, and documentation standards. Ideal for professionals transitioning into regulatory affairs roles.
Health Information Technologies Track Electives
BME 620 — Medical Imaging Systems (2 credits)
Comprehensive coverage of imaging modalities including X-ray, CT, MRI, PET, and ultrasound technologies. The course explores physical principles, instrumentation, image reconstruction, clinical applications, and quality assurance. Students gain foundational understanding of diagnostic imaging systems essential for health information technology specialization.
BME 625 — Diagnostic Ultrasound Instrumentation (2 credits)
Specialized course on ultrasound principles, including transducer design, beam physics, doppler ultrasound, and safety considerations. The course covers instrumentation specifics, image processing, clinical applications across specialties, and emerging technologies in ultrasound, from traditional imaging to therapeutic ultrasound applications.
BME 621 — Health Information Technologies (2 credits)
Focuses on health information system design, architecture, and management. Topics include data analytics, electronic health records (EHR), data security and privacy protection, interoperability standards, and emerging technologies. Students learn how information technology supports clinical decision-making and improves healthcare delivery.
HIM 622 — Medical Informatics, Telemedicine and E-Health (2 credits)
Examines the application of information and communication technologies (ICT) in healthcare delivery, including telemedicine platforms, e-health solutions, remote patient monitoring, and digital health tools. The course addresses ethical and legal issues in digital health while exploring how technology enables access and improves care delivery in diverse settings.
BME 627 — Science and Technologies in Healthcare (2 credits)
A broad introduction to healthcare technologies including medical sciences fundamentals, medical imaging technologies, surgical robotics, digital health platforms, and emerging innovations. This integrative course provides context for understanding how various technologies converge in modern healthcare ecosystems and clinical practice.
Frequently Asked Questions
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