Description de la formation

Master of Advanced Studies (MAS) is a postgraduate qualification awarded by universities and corresponds to at least 60 ECTS credits.

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 specialized training in Regulatory Affairs, Quality Management and Advanced Regulatory Affairs with particular focus on the European Medical Device Regulations. It addresses graduates interested in commencing a career in the regulation or quality control of medical devices and also targets those from complementary disciplines such as entrepreneurship, research and development, and management, seeking comprehensive and practical knowledge in this field.

Plan de la formation

Each CAS corresponds to at least 15 ECTS credits, which are earned by completing at least three modules. 

CAS Regulatory Affairs:
Module 1: Introduction Regulatory Affairs
Module 2: Pre-Submission Regulatory Affairs
Module 3: Post-Submission Regulatory Affairs

CAS Quality Management:
Module 1: Introduction to Quality Management
Module 2: Design Control: from input to validation
Module 3: Management and Usability Engineering

CAS Advanced Regulatory Affairs:
Module 1: Foreign Regulatory Affairs
Module 2: Combination Products
Module 3: Digital Health Technologies and Security
Module 4: Research and Development
Module 5: Clinical Trial Design and Performance

MAS Thesis (15 ECTS)
Internship (5 ECTS)