sitem-insel AG

M6 - Risk Management and Usability Engineering

Module leaders: Stefano Adami, confinis ag
Andrea Schütz Frikart, Confinis ag



Date and Credits

Start: 04.01.2021

Duration: 13 Weeks

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.  


Learning objectives

  • To understand risk management and risk based approach within the lifecycle of a medical device
  • To understand the requirements of the risk management process
  • To know how to perform Risk Management activities write risk management documents
  • To understand Usability principles and to know how to analyse potential usability risks

Learning content

  • The standards for risk management in medical devices
  • Risk based approach – parallel with ISO 13485 and Medical Device Regulation
  • Risk management Planning
  • Risk management in the design phases, Hazard identification, establishing severity, probability and the risk matrix
  • Risk Control measures – how can we reduce risk?
  • Techniques for risk analysis and risk management for production processes
  • Risk Management in post market phases including change management
  • Usability engineering standards for medical devices and designing usability Engineering studies