Abstract
This research paper reports on a case study in medical device development organizations to investigate risk management processes. Experiences from risk management method applications have been systematically captured and analyzed with action research. The analysis of risk management processes focused on risk identification, risk analysis, and risk planning and identified challenging problems in the risk management process with respect to the definition of the system boundary and system context, the use of scenarios as input to the risk identification, estimation of detectability during risk analysis, and action proposals during risk planning. The authors conclude that the risk management method has the potential to be used in development organizations to improve risk management processes.
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