Description de la formation

Regulatory specialists are integral to bringing novel medical devices to market. They require a breadth of managerial and interpersonal skills in addition to technical, clinical and legal knowledge. The program offers career specialised training for graduate students based on the newly implemented European Medical Device Regulations. In addition, the course provides participants with comprehensive knowledge and practical experience in: interna­tional RA, quality management, risk management, clinical evaluation of medical devices, technical writing and leadership. It addresses graduates interested in commencing a career in the regulation or quality control of medical devices. 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.

Plan de la formation

The MAS Medical Device Regulatory Affairs and Quality Assurance consist of a minimum of 68 ECTS over a course duration of 24 months. Students complete compulsory modules and two elective modules chosen. The course includes a 12 month industry-based learning component during which the MAS thesis is completed.