Conference
Software Quality. Process Automation in Software Development
About: Software Quality. Process Automation in Software Development is an academic conference. The conference publishes majorly in the area(s): Risk management plan & Risk assessment. Over the lifetime, 1 publications have been published by the conference receiving 12 citations.
Topics: Risk management plan, Risk assessment, Factor analysis of information risk, Risk analysis, Quantitative risk assessment software
Papers
17 Jan 2012
TL;DR: The experiences gained from an ongoing case study with a medical device development organisation are presented, with the aim of analysing and giving input to the organisation’s introduction of a software risk management process.
Abstract: Software failures in medical devices can lead to catastrophic situations. Therefore is it crucial to handle software related risks when developing medical devices. This paper presents the experiences gained from an ongoing case study with a medical device development organisation. This part of the study focuses on the two first steps of the risk management process, i.e. risk identification and risk analysis. The research is conducted as action research, with the aim of analysing and giving input to the organisation’s introduction of a software risk management process. The risk identification activities focus on user risks based on scenarios describing the expected use of the medical device in its target environment. Challenging problems have been found in the risk management process with respect to definition of the system boundary and system context, the use of scenarios as input to the risk identification and estimation of detectability used during risk assessment.
13 citations
Performance Metrics
| Year | Papers |
|---|---|
| 2012 | 1 |