DAS in Medical Device Regulatory Affairs and Quality Assurance

sitem-insel School, Unversität Bern

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.

To read the full MAS/DAS MDRQ brochure click on the documents section below.

Summary
Degree Diploma of Advanced Studies in Medical Device Regulatory Affairs and Quality Assurance MDRAQA University of Bern (DAS MDRAQA Unibe)
Start 09/2023
Length September 2023 – July 2025
Scope 37 ECTS
Cycle Annual
Flexible entry possible No
Single module visitable Yes
Place Bern
Language English
Admission Applicants must hold a Bachelor degree or higher degree in engineering, medicine, law, life sciences or other relevant scientific discipline. Professional experience is not mandatory.
Registration until 2023/08/15
Cost CHF 23'100
Organising institutions sitem-insel School, Unversität Bern
Partner sitem-insel AG
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Registration

Overview

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 of Advanced Studies in Medical Device Regulatory Affairs (RA) and Quality Assurance offers career specialised training for graduate students based on the newly implemented European Medical Device Regulations (MDR). 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.

What to expect from this program?

  • Connection with experts in the medical device regulatory industry
  • Close exchange with peers and lecturers for networking
  • Extensive knowledge within the industry and in-depth education
  • Keep up with the latest regulatory changes and implementations
  • Individual support in addition to a large flexibility of study formats
  • Internationally recognised degree from a prestigious Swiss university
  • Option to do an industry-based learning placement for a hands-on approach.

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.

Recent graduates will increase their career projects in an industry that is currently in need of trained professionals. The industry-based learning placement is a unique opportunity to gain insight into the industry. 
Mid-level experienced professionals will raise their proficiency to the next level, that allows them to approach different career options. The close collaboration with peers and lecturers expand your network internationally.

Structure of the Program

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. Please read the "structure of the program" section for further details.

The MAS Medical Device Regulatory Affairs and Quality Assurance consist of a minimum of 60 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. 

Location

The study program is embedded in sitem-insel, which, in collaboration with partners, provides participants access to a vast amount of hightech facilities and services.
The program is taught in a blended learning environment, allowing for flexible education that complements part time 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.

The DAS Medical Device Regulatory Affairs and Quality Assurance consist of a minimum of 37 ECTS over a minimum course duration of 14 months. Students complete Modules 1 to 6 and one elective module chosen from Modules 7 to 9 in addition to the DAS thesis. Programs are undertaken on a part time basis.
After successful participations, the University of Bern awards the degree Diploma 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

Advances 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 
DAS Thesis during industry-based learning placement
4

Lecturers and supervisors of this study program are professionals with high expertise - they bring many years of experience from industry, research, academia and life sciences. 

A faculty of industry experts

  • Sandra Soniec
  • Beat Lechmann
  • Juergen Berndt
  • Beat U. Steffen
  • Szymon Kurdyn
  • Hansjörg Riedwyl
  • Markus Wipf
  • Stefano Adami
  • Danielle Giroud
  • Mathias Eng

Admission Process

Applicants must hold a Bachelor degree or higher degree in engineering, medicine, law, life sciences or other relevant scientific discipline. Professional experience is not mandatory. If the applicant has no prior academic degree or professional experience, the study commission may define further conditions for the applicant to successfully complete the course.To complete the application, you will need the following documents:

  •     Motivation letter
  •     Signed copy of Confidentiality Declaration (see documents below)
  •     Copy of your resume/curriculum vitae (CV)
  •     Recent passport photo and a copy of the passport/ID

Upon successful registration, the participants will get a Campus Account from the University of Bern, which allows access to the student area of the University websites, the University´s WLAN network (eduroam), the use of library databases and of e-journals. MAS students will also receive a UNICARD and have access to sports, childcare and counselling facilities offered by the University of Bern.

Prospective students who would like to attend single modules may be admitted, provided places are still available. For details, please refer to the study regulations of sitem School. There is no claim to admission.

Application Deadlines

31 May and 15 August. Extensions of deadlines may be granted by the Directorate.

Tuition fees

Master of Advanced Studies (MAS): CHF 31'500.–
Diploma of Advanced Studies (DAS): CHF 23'100.–

The invoice for your first payment will be sent following written confirmation of admission. The fee for the DAS/MAS can be paid in full at once or in three installments. There is no entitlement to a refund or waiver of the course fees if parts of the course are not attended. Costs for travel, accommodation and catering are not included. Insurance is in the sole responsibility of participants (accident, travel, cancellation, etc.).
Withdrawal of the registration before the registration deadline is possible without cost consequences. In case of withdrawal after the registration deadline, the full course fee must be paid.

Associate Courses