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Medical Device Regulatory Affairs and Quality Assurance

What to expect from this program?

Objectives

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.

 

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.

 

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.

The Degrees

Students can undertake the program as a Master of Advanced Studies (MAS) or a Diploma of advanced studies (DAS).

  • MAS in Medical Device Regulatory Affairs and Quality Assurance:
    A minimum of 68 ECTS over a course duration of 24 months. Students complete Modules 1 – 9 and two elective modules chosen from modules 10 – 12. The course includes a 12 month industry based learning component during which the MAS thesis is completed.
  • DAS in Medical Device Regulatory Affairs and Quality Assurance:
    A minimum of 37 ECTS over a minimum course duration of 14 months. Students complete Modules 1 – 6 and one elective module chosen from Modules 7 – 9 in addition to the DAS thesis.

Degrees are awarded by the University of Bern upon successful completion of the program. Programs are undertaken on a part time basis.

Program Overview

Core Studies

M1 Research and Development Processes (2 ECTS)
Module 1 provides an overview of medical device research, development and verification processes in order to provide understanding of the regulatory environment.

M2 EU Medical Device Regulations Part A (6 ECTS)
Module 2 introduces the regulatory landscape and the European Medical Device Regulations (MDR). It focusses on the structure, interpretation and application of the MDR and includes a complex study of medical device classification.

M3 EU Medical Device Regulations Part B (6 ECTS)
Module 3 focusses on the interpretation and practical application of the general safety and performance requirements and technical documentation requirements as outlined in the MDR.

M4 EU Medical Device Regulations Part C (6 ECTS)
Module 4 is comprised of three submodules covering the regulation of labelling and instructions for use, conformity assessment and product registration, and post market surveillance and post market clinical follow-up.

M5 Quality Management (5 ECTS)
Module 5 provides a comprehensive and practical study of quality assurance as it pertains to medical devices.

M6 Risk Management and Usability Engineering (5 ECTS)
Module 6 teaches the purpose, methodology and regulation of medical device risk identification, assessment and mitigation. The module includes a comprehensive study of usability regulation, assessment and risk assessment.

Advanced Studies

M7 Clinical Evaluation for Medical Devices (4 ECTS)
Module 7 concentrates on the clinical evaluation required to demonstrate the device’s intended purpose without exposing users and patients to unnecessary risk. The module covers the collection and reporting of pre- and post-market clinical data including safety reporting.

M8 Digitalisation, Software and Cybersecurity (3 ECTS)
Module 8 focuses on the regulatory framework for medical device software. It provides an overview of the software development lifecycle and the management of software quality. The module additionally covers cybersecurity and the regulation of devices based on artificial intelligence.

M9 International Regulatory Affairs (3 ECTS)
Module 9 provides an overview of international regulatory affairs with a particular focus on the US and Asian medical device regulations and path to market.

Elective Studies

M10 Combination Products (3 ECTS)
Combination products include a combination of a medical device, and/or drug and/or biologic. Module 10 will cover the corresponding regulatory requirements for each component, their similarities and differences. The market launch of a combination product on the market will be discussed.

M11 Market Access and Pricing (2 ECTS)
Module 11 introduces the complementary topics of health economics & outcomes research, pricing & reimbursement and health policy including health technology evaluation. In a case study, the optimal price level for a product as well as a launch sequence to optimise profitability will be developed.

M12 Leadership, Team and Project Management for Regulatory Experts (2 ECTS)
Regulatory and quality experts inhabit critical roles that rely on successful intra- and inter-department communication, the management and motivation of teams and the management of tasks and projects. Module 12 aims to provide students with the skills and confidence to work successfully within a regulatory team and within a regulatory managerial position.

Start and Duration
The program will commence in May 2020 and is designed to run for a minimum of 2 semesters (DAS) or 4 semesters (MAS).

The MAS course duration is 24 months.

The DAS can be completed in a minimum of 14 months with duration dependent on the chosen elective module.

 

Location
On-sight 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.

 

Language
The course language is English.

 

Industry Based Learning

The MAS program includes a 12 month industry placement within a professional medical device regulatory environment in the second year of the program. The MAS thesis will be prepared during the placement and course work will complement the placement.

 

Enrolment
Participants will be registered at the University of Bern. Upon successful registration, participants will get a campus account. MAS students will receive a UNICARD and have access to university services, sports, childcare and counselling facilities offered by the University of Bern.

Admission Requirements
Applicants must hold a Bachelor degree or higher degree in pharmacy, biology, medicine, law, engineering or other relevant scientific discipline. No professional experience is required.

 

Fees
The fee for the MAS or DAS in Medical Device Regulatory Affairs and Quality Assurance is:

MAS CHF 31’500. –
DAS CHF 23’100. –

 

Contact and Registration
Places available but limited.

Registration deadline to be announced.

Please download and fill out the registration form (see downloads section) and email it to 
Mail: school@sitem.unibe.ch
Phone: +41 31 664 64 00

Participants will be registered at the University of Bern.

 

Further Information
For further questions about the study program in Medical Device Regulatory Affairs and Quality Assurance, please contact:

Prof. Dr. Juergen Burger, Director School

Dr. Kate Gerber, Program Coordinator

Jennifer Fischer, Administration and Communication