Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Standalone Modules

Module 1 - Research and Development Processes

 

Content

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

Module 1 starts in August each year.
The completion takes approximately 4 weeks.

Credits

2 ECTS

Fee

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

Reference

03.001

 

Module Leaders

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. Principal inventor of more than 40 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.