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Frequently requirements are written in natural language which may cause communication problems-misunderstandings. Misunderstandings are sources of risk that can severely impact the whole software development project. Since patterns and templates are tools for improving the quality of requirements, the question arises whether they can be treated as risk guards. In the paper we propose a method based...
We have investigated approaches in the literature to assess the quality of the software architectures of medical devices, and have found evidence that there is a lack of methodologies for evaluating the software architecture design aspects of medical devices that might affect system safety. Such evidences were identified when evaluating the software architecture of the FDA Generic Infusion Pump searching...
Safety assurance and certification are amongst the most expensive and time-consuming activities in the development of safety-critical systems. Deeming a system to be safe involves gathering convincing evidence to argue the safe operation of the system, usually according to the requirements of some safety standard. To handle large collections of safety evidence effectively, practitioners need knowledge...
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