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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

 Modules Module Leaders  ECTS 
 M1 - Research and Development Processes  Prof. Dr. Jürgen Burger, Beat Lechmann  2
 M2 - EU Medical Device Regulations Part A  Sandra Soniec, Dr. Jürgen Berndt  6
 M3 - EU Medical Device Regulations Part A  Dr. Jürgen Berndt, Beat U. Steffen  6
 M4 - EU Medical Device Regulations Part A  Dr. Jürgen Berndt, Beat U. Steffen, Szymon Kurdyn, Dr. Andrea Biasiucci  6
 M5 -  Quality Management  Markus Wipf, Susanne Wyss-Lanz  5
 M6 - Risk Management and Usability Engineering  Stefano Adami  5

Advanced Studies

 Modules Module Leaders  ECTS 
M7 - Clinical Evaluation for Medical Devices Danielle Giroud 4
M8 - Digitalisation, Software and Cybersecurity Hansjörg Riedwyl, Mathias Eng, Dr. Larissa Naber 3
M9 - International Regulatory Affairs Viky Verna, Cherry Marty 3

Elective Studies

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

MAS Thesis

 Modules Module Leaders  ECTS 
MAS Thesis during industry-based learning placement
16