Available courses

RAQ 520 QUALITY MANAGEMENT SYSTEMS

Course categoryRegulatory Affairs

This course is designed to provide students with a comprehensive understanding of the principles and practices of quality management in organizations in the medical technologies industry. The course will cover the various components of a Quality Management System (QMS), including planning, control, assurance, and improvement. The course will cover the regulatory requirements and industry standards for QMS, including ISO 9001, ISO 13485, FDA regulations, risk management, and Good Manufacturing Practices (GMP). Students will learn about the role of QMS in ensuring compliance with these requirements and standards and in achieving organizational goals such as customer satisfaction, continuous improvement, and operational efficiency. Students will be provided with practical examples and case studies to help them apply their learning to real-world situations. Students will gain insights into designing, implementing, and maintaining Quality Management Systems (QMS) to ensure compliance with quality  requirements. They will develop a solid understanding of QMS principles and practices, enabling them to design, implement, and maintain QMS in accordance with regulatory requirements and industry standards.

! MOODLE TRAINING !

Course categoryRegulatory Affairs

This training course on the Moodle platform is designed to familiarize users with the virtual learning environment. Through an interactive tour, participants will explore the main features of the platform, including how to navigate the course, access resources, and efficiently submit their assignments. The goal is to ensure that all users feel comfortable using the platform to maximize their academic performance.

Teacher: Admin User

HUM500 - ETHICS AND VALUES

Course categoryRegulatory Affairs

The Ethics and Values Seminar course is designed to discuss the role of ethics and values in leadership and how leaders can make ethical decisions that positively impact their organizations and society. The curriculum in the Ethics and Values Seminar course covers topics such as ethical decision-making, ethical leadership, values-based leadership, organizational culture, social responsibility, and sustainability. Students also analyze case studies and engage in discussions and activities that help them develop their critical thinking, communication, and problem-solving skills. The students gain an understanding of the importance of ethical leadership and how it can promote trust, respect, and accountability within an organization. Graduates of this course are equipped to lead with integrity, make ethical decisions that positively impact their organizations, and contribute to the development of a more just and sustainable society. In the regulatory affairs and quality assurance context, students apply ethical principles in medical device and pharmaceutical companies to always seek accountability and responsibility for patient safety and product effectiveness.

RAQ500 - INTRODUCTION TO REGULATORY AFFAIRS

Course categoryRegulatory Affairs

This course is designed to provide students with an overview of the regulatory environment and the key principles and practices of regulatory affairs in the medical device, food and pharmaceutical companies. The course covers the regulations and requirements related to the development, approval, marketing and manufacturing of medical products in various industries, such as pharmaceuticals, biotechnology, medical devices, food, and cosmetics. The course covers topics such as regulatory agencies and their roles, regulatory processes and submissions, clinical trials, quality assurance, risk management, intellectual property, product labeling, and advertising and promotion. Students will also learn about the global regulatory landscape and main regulatory requirements across major markets globally. Students will gain an understanding of the importance of regulatory compliance and the role of regulatory affairs professionals in ensuring that products meet regulatory requirements. The students also learn about the key challenges and opportunities in the regulatory environment, including regulatory affairs roles for the development, marketing, and manufacturing of safe and effective products for consumers.

Teacher: Admin User

ENT510 - LEADERSHIP, TEAMWORK AND SUCESS PRINCIPLES

Course categoryHumanities

This course is designed to provide students with an understanding of the key principles and practices of effective leadership, teamwork, effort, and commitment to success and effective service, and how they contribute to individual and organizational success. The course typically covers topics such as leadership styles, communication skills, team dynamics, conflict resolution, goal setting, project management and good service principles. The course includes case studies, group projects, and experiential learning activities that allow students to practice and apply these principles in real-world scenarios. Additionally, students may explore various leadership and teamwork theories and models, and how they can be used to build successful teams and achieve organizational goals. Students will develop the skills needed to be effective leaders and team members, including the ability to communicate clearly, listen actively, motivate others, and resolve conflicts. They will also gain an understanding of how to set and achieve goals, build trust and collaboration, and adapt to changing circumstances. In the regulatory affairs and quality assurance context, students apply leadership and teamwork principles to influence leaders and team members to bring medical device and pharmaceutical companies into compliance with regulations.

BME611 - MEDICAL DEVICES

Course categoryMedical Devices

This course provides students with the knowledge about the different types of medical devices, including diagnostic and therapeutic devices, and the various components that make up these devices. They will also be introduced to the various materials and technologies used in the manufacture of medical devices. The course will cover electrophysiology devices, medical imaging, medical implants, clinical laboratory equipment, hospital equipment and therapeutic devices and their risk and benefits. Students will have a comprehensive understanding of various types of medical devices, their use in healthcare applications, the medical device industry and the processes involved in designing, manufacturing, and bringing medical devices to market.

Teacher: Admin User

ENT682 - ENTREPRENEURIAL MARKETING

Course categorySpring II

The Entrepreneurial Marketing course, a key component of the Master of Science in Innovation and Entrepreneurship in Medical Technologies program, provides students with an in-depth understanding of how to develop and execute marketing strategies specifically tailored to the medical technology sector. Building on the foundational concepts outlined in Marketing Release: 4th Edition by C. Shane Hunt, this course explores the unique challenges entrepreneurs face when bringing innovative medical technologies to the market.

 

Students will gain practical insights into how to craft value propositions, segment healthcare markets, and design marketing strategies that resonate with diverse stakeholders, including healthcare providers, regulators, investors, and patients. The course will emphasize strategic thinking, hands-on marketing techniques, and the integration of digital tools to promote medical innovations in a highly competitive and regulated environment.

Teacher: Admin User