Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

MAS Medical Device Regulatory Affairs and Quality Assurance


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 Modules 1 to 9 and two elective modules chosen from modules 10 to 12. The course includes a 12 month industry-based learning component during which the MAS thesis is completed.

After successful participations, the University of Bern awards the degree Master of Advanced Studies. The corresponding certificantes will disclose the content and achievements of the program. 

Core Studies

Core Studies
 Modules Module Leaders  ECTS 
 M1 - Research and Development Processes  Beat Lechmann  2
 M2 - EU Medical Device Regulations Part A  Helena Lacalle, Sandra Soniec, Heike Idink  6
 M3 - EU Medical Device Regulations Part B  Pamela Joller, Heike Idink, Helena Lacalle  6
 M4 - EU Medical Device Regulations Part C  Helena Lacalle, Beat U. Steffen, Szymon Kurdyn  6
 M5 -  Quality Management  Markus Wipf, Susanne Wyss-Lanz  5
 M6 - Risk Management and Usability Engineering  Stefano Adami  5

Advanced Studies

Advanced Studies
 Modules Module Leaders  ECTS 
M7 - Clinical Evaluation for Medical Devices Danielle Giroud 4
M8 - Digitalisation, Software and Cybersecurity Larissa Naber, Mathias Eng, Peter Roka  3
M9 - International Regulatory Affairs Cherry Marty 3

Elective Studies

Elective studies
 Modules Module Leaders  ECTS 
M10 - Combination Products Beat U. Steffen 3
M11 - Market Access and Pricing Mike Wallenstein 2
M12 - Leadership, Team and Project Management for Regulatory Experts Farzana Malik 2

MAS Thesis

 Modules Module Leaders  ECTS 
MAS Thesis during industry-based learning placement