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
Upon successful completion of this module, participants understand risk management and risk-based approach within the lifecycle of a medical device, the requirements of the risk management process, know how to perform risk management activities and write risk management documents and are aware of the usability principles and know how to analyse usability risks.
Learning content
This module includes 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 and risk control measures - how can we reduce risk? It furthermore covers technqiues for risk analyses and risk manage-ment for production processes, risk management in post-market phases, including change management, and usability engineering standards for medical devices and designing usability engineering studies.
Start & Duration
Module 6 starts in January each year.
The completion takes approximately 13 weeks.
Credits
5 ECTS
Fee
The cost of this standalone module is 5250.– SFr.
Reference
03.006