相关论文: On Medical Device Software CE Compliance and Confo…
Testing of autonomous systems is extremely important as many of them are both safety-critical and security-critical. The architecture and mechanism of such systems are fundamentally different from traditional control software, which appears…
Regulatory compliance is a well-studied area, including research on how to model, check, analyse, enact, and verify compliance of software. However, while the theoretical body of knowledge is vast, empirical evidence on challenges with…
Software implements a significant proportion of functionality in factory automation. Thus, efficient development and the reuse of software parts, so-called units, enhance competitiveness. Thereby, complex control software units are more…
Agile software development methods have been suggested as useful in many situations and contexts. However, only few (if any) experiences are available regarding the use of agile methods in embedded domain where the hardware sets tight…
Cyber Physical Systems are systems controlled or monitored by computer-based programs, tightly integrated networks, sensors, and actuators. Software development of CPS has become so difficult that it represents most of the cost of CPS…
Systematic application of software metric techniques can lead to significant improvements of the quality of a final software product. However, there is still the evident lack of wider utilization of software metrics techniques and tools due…
The idea of automatizing the assessment of objectoriented design is not new. Different approaches define and apply their own quality models, which are composed of single metrics or combinations thereof, to operationalize software design.…
We selected 29 medical imaging projects from 48 candidates, assessed 10 software qualities by answering 108 questions for each software project, and interviewed 8 of the 29 development teams. Based on the quantitative data, we ranked the MI…
[Context and motivation]: Understanding and interpreting regulatory norms and inferring software requirements from them is a critical step towards regulatory compliance, a matter of significant importance in various industrial sectors.…
Control systems are sets of interconnected hardware and software components which regulate the behaviour of processes. The software of modern control systems rises for some years by requirements regarding the flexibility and functionality.…
The article presents the first results of a PhD study connected to testing of safety critical medical devices: a systematically executed case study at a Hungarian manufacturer of medical devices. The article shortly describes the process of…
Software testing is an important phase in the software development life-cycle because it helps in identifying bugs in a software system before it is shipped into the hand of its end users. There are numerous studies on how developers test…
Computational models are increasingly used in high-impact decision making in science, engineering, and medicine. The National Aeronautics and Space Administration (NASA) uses computational models to perform complex experiments that are…
Critical embedded systems (CES) have become ubiquitous in whether medical, automotive, or industrial. Software failures in such systems are potentially disastrous and could lead to serious consequences not only financially but also…
The software development lifecycle depends heavily on the testing process, which is an essential part of finding issues and reviewing the quality of software. Software testing can be done in two ways: manually and automatically. With an…
Robotic systems are multi-dimensional entities, combining both hardware and software, that are heavily dependent on, and influenced by, interactions with the real world. They can be variously categorised as embedded, cyberphysical,…
The main problems of Software Engineering appear as a result of incompatibilities. For example, the quality of organization of the production process depends on correspondence with existent resources and on a common understanding of project…
Software is now a vital scientific instrument, providing the tools for data collection and analysis across disciplines from bioinformatics and computational physics, to the humanities. The software used in research is often home-grown and…
Software of Unknown Provenance, SOUP, refers to a software component that is already developed and widely available from a 3rd party, and that has not been developed, to be integrated into a medical device. From regulatory perspective, SOUP…
We present our ongoing work on requirements specification and analysis for the geographically distributed software and systems. Developing software and systems within/for different countries or states or even within/for different…