sitem Center for Translational Medicine and Biomedical Entrepreneurship

Standalone Modules

Module 1 - Research and Development Processes



Module 1 provides an overview of medical device research, development and verification processes in order to provide understanding of the regulatory environment.

Learning objectives

Module 1 teaches participants to understand the different phases in the undertaking during the development of medical devices, the design process and its constraints, the process involved in design verification, validation and evaluation, and they see the importence of the design process to medical device regulatory affairs and quality management.

Learning content

It includes the introduction to the design and development process, development models and project planning, as well as product specification and design inputs. It further contains the medical device design, verification and validation, and the design and development process output. 

Start & Duration

2020: 1 Spetember 2020
2021: TBC

The completion of this module takes approximately 3 weeks.




The cost of this standalone module is 2'100.– SFr.




Module Leaders

Professor for Translational Medicine and Entrepreneurship, University of Bern

Prof. Dr. Jürgen Burger

Jürgen Burger is Professor of Translational Medicine and Entrepreneurship at the Medical Faculty of the University of Bern. He is also director of the Swiss School in Translation and Entrepreneurship in Medicine at sitem-insel AG. The focus of Jürgen Burger's research lies in bringing innovative treatment methods and therapeutic / diagnostic systems into clinical use. Special focus is on intelligent implants and surgical instruments in combination with pharmaceutical products.

Director R&D Innovation, Trauma at DePuy Synthes Companies of J&J

Beat Lechmann

Beat Lechmann heads external innovation in R&D at DePuy Synthes companies of Johnson & Johnson. He is named inventor on 36 issued U.S. patents and investigator on 8 published scientific posters and publications. He earned his Bachelor’s Degree from the University of Applied Science, Division Micro Mechanics and a Degree in Industrial Engineering. He is active member in various Advisory Boards and Program Committees.