sitem Center for Translational Medicine and Biomedical Entrepreneurship

Medical Device Regulatory Affairs and Quality Assurance



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.

Who is this program for?

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.

Overview

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.

  • You connect with experts in the medical device regulatory industry and experience close exchange with peers and lecturers for networking.
  • You acquire extensive knowledge within the industry. As a working professional, the in-depth education will raise your proficiency. 
  • You receive individual support in addition to a large flexibility of study formats - so you can be confident you reach your goals.
  • You obtain an internationally recognised degree from a prestigious Swiss university in the field of medicine. 
  • You have the option to do an industry-based learning placement for a unique hands-on approach.

Faculty

The faculty is comprised of leading experts from industry and academics, and includes specialists from regulatory agencies with extensive international experi­ence in the regulation and quality assurance of medical technologies.

Study Program and Learning Environment

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.

MAS / DAS

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. 

The program addresses university graduates interested in commencing a career in the regulation or quality control of medical devices. 

Modules

Admission

Annual Start

The study program starts in September each year (September 2022).

Location

On-site classes are held at sitem-insel, the Swiss Institute for Translational and Entrepreneurial Medicine in Bern, Switzerland. E-learning courses may be performed at home. In case of University closures due to Covid-19, planned on-site lessions will be held in virtual classrooms. 

Language

The course language is English.

Requirements

Applicants must hold a BSc or higher degree in engineering, computer science, pharmacy, life science, health management, medicine, law or other relevant scientific discipline. No professional experience is required.
Students can bring a proposal for an own translational medicine project on which they will work during the MAS thesis.

Available Services

Upon successful registration, the participants will get a campus account, which includes an email account in the SWITCH network. MAS students will receive a Unicard and have access to sports, childcare and counselling facilities offered by the University of Bern. 

Fees & Funding

Fees

The following fees cover all expenses within your chosen study program.

DAS Medical Device Regulatory Affairs and Quality Assurance

CHF 23'100.– for each

MAS Medical Device Regulatory Affairs and Quality Assurance

CHF 31'500.–

We accept payment in installments at no additional costs, please contact us for individual conditions.

Funding

Limited scholarships are available to support MAS Translational Medicine and Biomedical Entrepreneurship participants with promising medical projects.  

Those are presented and evaluated at the annual Scholarship Award event by sitem-insel School in summer. Applications are opening in April 2021.

Registration & Contact

Registration

Places are available but limited to 15 students per cohort.
Registration is possible throughout the year, please reach out to us: school.sitem@unibe.ch.

Contact

For further questions about the study program, please contact

Christian Rosser, Interim Director School

Mark Illi, Managing Co-Director

Mei Wang, Program Administrator