Overview Participants The program addresses university graduates interested in commencing a career in the regulation or quality control of medical devices. The program prepares students to work as a regulatory officer or quality manager within a medical device company or regulatory body. The program also targets those from complementary disciplines such as entrepreneurship, research and development, and management, seeking comprehensive and practical knowledge of the regulation of medical devices according to the new European MDR. You connect with experts in the medical device regulatory industry and experience close exchange with peers and lecturers for networking. You acquire extensive knowledge within the industry. As a working professional, the in-depth education will raise your proficiency. You receive individual support in addition to a large flexibility of study formats - so you can be confident you reach your goals. You obtain an internationally recognised degree from a prestigious Swiss university in the field of medicine. You have the option to do an industry-based learning placement for a unique hands-on approach. Faculty The faculty is comprised of leading experts from industry and academics, and includes specialists from regulatory agencies with extensive international experience in the regulation and quality assurance of medical technologies. Study Program and Learning Environment The program is taught in a blended learning environment, allowing for flexible education that complements professional work. The courses utilise e-learning, peer learning and interactive discussions with experts, on site lectures, workshops and case studies. The MAS program additionally includes an industry based learning placement in the second year of study. Class sizes are limited to ensure high quality personal education that fosters communication and professional networking.
MAS / DAS Depending on your needs we offer a MAS or a DAS. The program consists of six modules covering core aspects relevant for the research and development, international regulations, and quality and risk management. Modules 7 to 9 are advanced studies, that are fully implemented in the MAS study program and acts as electives for the DAS study program. Further, MAS participants select two elective modules from modules 10 to 12 and undertake a industry-learning placement. The program addresses university graduates interested in commencing a career in the regulation or quality control of medical devices. Schliessen Study Programs Please select MAS MDRQ DAS MDRQ
Modules Module Content and Leaders Please select Module 1 - Research and Development Processes Module 2 - EU Medical Device Regulations Part A Module 3 - EU Medical Device Regulations Part B Module 4 - EU Medical Device Regulations Part C Module 5 - Quality Management Module 6 - Risk Management and Usability Engineering Module 7 - Clinical Evaluation for Medical Devices Module 8 - Digitalisation, Software and Cybersecurity Module 9 - International Regulatory Affairs Module 10 - Combination Products Module 11 - Market Access and Pricing Module 12 - Leadership, Team and Project Management for Regulatory Experts
Admission Annual Start The study program starts in September each year. Location On-site classes are held at sitem-insel, the Swiss Institute for Translational and Entrepreneurial Medicine in Bern, Switzerland. E-learning courses may be performed at home. Language The course language is English. Requirements Applicants must hold a BSc or higher degree in engineering, computer science, pharmacy, life science, health management, medicine, law or other relevant scientific discipline. No professional experience is required. Available Services Upon successful registration, the participants will get a campus account, which includes an email account in the SWITCH network. MAS students will receive a Unicard and have access to sports, childcare and counselling facilities offered by the University of Bern.
Fees & Funding Fees The following fees cover all expenses within your chosen study program. DAS Medical Device Regulatory Affairs and Quality Assurance CHF 23'100.– for each MAS Medical Device Regulatory Affairs and Quality Assurance CHF 31'500.– We accept payment in installments at no additional costs, please contact us for individual conditions.
Registration & Contact Registration & Contact Places are limited per cohort. The registration deadline for the MAS program is 15th July. Registration for standalone modules are possible throughout the year. We are happy to schedule a call and discuss the study format that suits your needs the best. Please reach out to us via school.sitem@unibe.ch.