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The usability and, more generally, the overall user-perceived quality of medical devices is an important aspect, which is often insufficiently addressed in the corresponding system development activities. Fortunately, the development of new standards like IEC/DIN EN 60601-1-6 is strengthening the focus on usability/user acceptance issues. This paper argues for the need to consider usability and user...
Inspections are widely used and studies have found them to be effective in uncovering defects. However, there is less data available regarding the impact of inspections on different defect types and almost no data quantifying the link between inspections and desired end product qualities. This paper addresses this issue by investigating whether design inspection checklists can be tailored so as to...
The medical device industry is a constantly growing domain which makes use of more and more software products. Given the importance to this industry of dependable software components, rigorous software engineering techniques would seem to have an important role to play. However, in a recent survey of the industry we found a lower than expected rate of adoption of certain sound software engineering...
A systematic approach to decision making in software engineering is required, for instance, if an organization aims at achieving CMMI level three. Rational decision making regarding the selection and introduction of SE technologies requires adequate information about their suitability for the intended organizational context. Research is often unable to provide such information, and this could be one...
Different quality assurance techniques can be applied in the software development lifecycle to improve the quality of a product. Today, no holistic approach for planning and customizing inspection and testing techniques in a given context exists. In this paper, we present a framework which consists of the main aspects necessary for a systematic planning of quality assurance activities in different...
Inspections, Reviews and walkthroughs are highly effective and efficient means for static software quality assurance. During the last three decades different variations and facets evolved on how to perform and apply such techniques, ranging from Fagan inspection over structured walkthroughs to Peer Reviews and simple Desk Checks. What is missing today is a systematic approach on how to select and...
A wide variety of the functions provided by today's medical devices relies heavily on software. Most of these capabilities could not be offered without the underlying integrated software solutions. As a result, the medical device industry has become highly interdisciplinary. Medical device manufacturers are finding an increasing need to incorporate the research ideas and results from traditionally...
Defect measurement plays a crucial role when assessing quality assurance processes such as inspections and testing. To systematically combine these processes in the context of an integrated quality assurance strategy, measurement must provide empirical evidence on how effective these processes are and which types of defects are detected by which quality assurance process. Typically, defect classification...
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