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This course provides students with a comprehensive understanding of leadership, teamwork, and success principles and how they contribute to individual and organizational growth. Students explore leadership theories, communication strategies, conflict resolution, and goal-setting techniques, as well as practical frameworks for leading effective teams. Through real-world exercises, case studies, and self-assessment tools, learners develop skills to motivate others, adapt to change, and lead ethically and collaboratively in professional environments — including regulatory and quality contexts in the biomedical industry.

This course provides graduate students with a comprehensive understanding of how design controls are applied throughout the medical product development lifecycle to meet regulatory, safety, and quality requirements. Emphasizing the FDA Quality System Regulation (QSR) 21 CFR 820.30, students will learn how to define user needs, manage design inputs and outputs, perform verification and validation (V&V), conduct risk management, and prepare compliant documentation such as the Design History File (DHF) and Device Master Record (DMR). Through practical assignments and case studies, learners will gain the ability to apply design control principles, align with regulatory expectations, and ensure product safety and effectiveness across the medical device lifecycle.

This course explores the foundations of ethics and moral reasoning that guide personal, professional, and societal decision-making. Through case studies, discussions, and interactive activities, students will analyze major ethical theories—including utilitarianism, deontology, virtue ethics, and care ethics—and apply them to real-world dilemmas in business, technology, healthcare, and the environment. The course encourages reflection on personal values, ethical leadership, and social responsibility, helping students build critical thinking skills and ethical awareness essential for professional and personal growth.

This course provides an in-depth study of regulatory frameworks governing medical devices, with emphasis on pre-market requirements, compliance strategies, quality systems, risk management, and post-market surveillance. Students examine FDA regulations, international regulatory considerations, enforcement mechanisms, and the role of regulatory affairs professionals in medical device law.

Through applied case studies, regulatory document analysis, and structured discussions, students develop strategic insight into navigating medical device regulations, supporting product approval, ensuring compliance, and managing regulatory risk throughout the product lifecycle.

This course examines the latest scientific and technological innovations shaping modern healthcare. Through an interdisciplinary lens, students explore advances in medical devices, digital health, biotechnology, genomics, AI, and telemedicine. The course emphasizes how innovation enhances patient care and outcomes while also introducing ethical, legal, and regulatory considerations. Students will engage in critical discussions, applied assignments, and technology briefs designed to connect science, policy, and innovation in 21st-century healthcare.

This course provides students with a foundational understanding of human biological systems and processes essential to the design, development, and application of medical devices. It integrates key disciplines — biochemistry, cell biology, physiology, genetics, pharmacology, immunology, and pathology — with clinical relevance to biomedical engineering. Students will explore how medical technologies interact with physiological systems, support diagnosis and therapy, and align with patient safety. The course emphasizes a systems-based approach connecting medical sciences to innovation, regulatory considerations, and ethical implications in medical device design.

This course introduces students to the principles, standards, and regulatory requirements that govern Quality Management Systems (QMS) for medical devices. Emphasis is placed on understanding and applying ISO 13485, FDA Quality System Regulation (21 CFR Part 820), and ISO 14971 for risk management. Students will develop practical skills in design controls, corrective and preventive actions (CAPA), complaint handling, internal audits, and post-market surveillance. Real-world case studies and FDA warning letters are used to illustrate compliance, continuous improvement, and quality assurance best practices in the medical device industry.

This course provides a comprehensive introduction to the principles, processes, and global frameworks that govern pharmaceutical and medical device regulation. Students will examine major regulatory systems, drug development pathways, clinical trials, quality assurance, labeling standards, and post-marketing surveillance.

Emphasis is placed on documentation standards, Good Manufacturing Practices (GMP), Chemistry, Manufacturing, and Controls (CMC), labeling and promotional regulations, and global harmonization efforts such as ICH guidelines. Through real-world case studies, regulatory documents, and weekly assignments, students will develop practical skills to analyze regulatory strategies, evaluate compliance risks, and support market authorization and lifecycle management of pharmaceutical and medical products in both U.S. and international contexts.

This course explores the critical relationship between innovation and sustainability, equipping students with the strategic mindset and practical tools to lead impactful and sustainable change in the medical technology and healthcare sectors. Through contemporary global challenges, students examine how sustainability can act as a catalyst for innovation, competitive advantage, and long-term value creation.

Key topics include sustainable business model innovation, purpose-driven growth, ESG strategy, stakeholder engagement, organizational transformation, and the role of digital technologies in advancing sustainability goals. The course integrates theory, real-world case studies, and applied projects aligned with healthcare entrepreneurship and MedTech innovation.

This course provides a comprehensive introduction to the fundamental principles of medical physics and their application to diagnostic and therapeutic technologies in modern healthcare. Students will explore the physics of radiation, dosimetry, and imaging systems such as X-ray, CT, MRI, ultrasound, and nuclear medicine. The course also covers radiation therapy techniques, radiation protection, quality assurance, and emerging technologies including AI, photoacoustic imaging, and FLASH radiotherapy. Through readings, assignments, and discussions, students will connect theoretical physics with clinical applications and regulatory frameworks (FDA, IEC, ISO).

This course provides an in-depth exploration of regulatory requirements, practical processes, and international considerations related to medical product labeling. Students examine the full lifecycle of healthcare product labeling for pharmaceuticals and medical devices across multiple jurisdictions, including the United States, European Union, Canada, and selected global markets.

The course addresses content development, core and target labeling strategies, investigational product labeling, medical device instructions for use, and emerging product categories such as cannabis-based therapeutics. Through regulatory analysis, real-world case studies, and applied assignments, students develop the expertise needed to design, evaluate, and manage compliant labeling strategies that support patient safety, regulatory approval, and global market access.

This course offers a comprehensive examination of the evolving global landscape of medical device regulation. Students explore regulatory frameworks in the United States and the European Union, including FDA pathways, EU MDR/IVDR, and their intersections with data protection regulations such as GDPR. The course places strong emphasis on emerging technologies—including AI/ML-based medical devices, digital health solutions, and home healthcare innovations—and the regulatory challenges they introduce.

Through in-depth readings, case analyses, and discussions, students develop the ability to navigate complex regulatory environments while balancing innovation, patient safety, ethical considerations, and legal accountability within the medical device ecosystem.

This course provides a practical and comprehensive overview of product safety risk management and performance testing for medical and in vitro diagnostic devices. Students will learn how to identify, evaluate, and mitigate risks across the entire device lifecycle using international frameworks such as ISO 14971, ISO 13485, and FDA QMSR. The course combines theory with real-world examples, focusing on design assurance, hazard analysis, usability, and post-market monitoring to ensure the safety and performance of medical technologies.