sitem-insel AG

M1 - Research and Development Processes

Module leaders: Prof. Dr. Jürgen Burger, University of Bern & sitem-insel
Beat Lechmann, Depuy Synthes Companies

Date and Credits

Start: 01.09.2020

Duration: 3 Weeks


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

Learning objectives

  • To understand the different phases in the undertaken during the development of medical devices
  • To understand the design process and its constraints
  • To Understand the processes involved in design verification, validation and evaluation
  • To understand the importance of the design process to medical device regulatory affairs and quality management

Learning content

  • Introduction to the design and development process
  • Development models and project planning
  • Product specification and design inputs
  • Medical device design, verification and validation
  • Design and development process output