The Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies equips students with the knowledge 
and skills necessary to navigate the complex regulatory landscape and manage compliance with applicable laws, regulations, and standards in the devices and life sciences industry. The program focuses on the study of the regulatory and quality requirements related to the development, approval, marketing and manufacturing of products in various industries, such as pharmaceuticals, biotechnology, medical devices, food, and cosmetics. This program is designed to provide students with the knowledge and skills necessary to understand and comply with complex regulatory environments to ensure that products meet regulatory and quality requirements and relevant laws and regulations. Students can advance their knowledge of international regulatory affairs laws and procedures while also gaining the leadership skills necessary to succeed in the fields of regulatory science and quality assurance. The 30-credit Medical Device Regulatory Affairs stream specialization of the Master of Science in Medical Devices, Regulatory Affairs, and Health Information Technologies is available. 

With concentrations on Medical Devices and Pharma, the Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies at Aleph prepares interdisciplinary professionals to address current and future challenges and opportunities in the market. 


The curriculum in the Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies program includes courses that cover topics such as ethics and leadership, regulatory strategy, clinical trials, quality assurance, risk management, product development, global regulations, and statistical analysis. Students will also learn about quality management systems, validation processes, and auditing techniques

MAREAF001 | BME 611 – MEDICAL DEVICES

Course categoryMaster of Science in Regulatory Affairs and Quality Assurance in Medical Technologies
Teacher: Jorge Millan