相关论文: On Medical Device Software CE Compliance and Confo…

In Model-Based Design of Cyber-Physical Systems (CPS), it is often desirable to develop several models of varying fidelity. Models of different fidelity levels can enable mathematical analysis of the model, control synthesis, faster…

Regulatory affairs, which sits at the intersection of medicine and law, can benefit significantly from AI-enabled automation. Classification task is the initial step in which manufacturers position their products to regulatory authorities,…

Most engineers use measurements to make decisions. However, measurements are rarely used for decisions about constructing software products. While many approaches to measuring attributes of software (``metrics'') have been developed, they…

The increasing popularity of machine learning approaches and the rising awareness of data protection and data privacy presents an opportunity to build truly secure and trustworthy healthcare systems. Regulations such as GDPR and HIPAA…

Organizations need to manage numerous business processes for delivering their services and products to customers. One important consideration thereby lies in the adherence to regulations such as laws, guidelines, or industry standards. In…

Industrial standards for developing medical device software provide requirements that conforming devices must meet. A number of reference software architectures have been proposed to develop such software. The ISO/IEC 25010:2011 family of…

Designing of microprocessor based controllers requires specific hardware as well as software programming. Programming depends upon type of the software whether operating software or application software. Programming requires knowledge of…

Software product quality can be defined as the features and characteristics of the product that meet the user needs. The quality of any software can be achieved by following a well defined software process. These software process results…

Digital medical imaging laboratories contain many distinct types of equipment provided by different manufacturers. Interoperability is a critical issue and the DICOM protocol is a de facto standard in those environments. However,…

Over the last decade the successful design and fabrication of complex MEMS (MicroElectroMechanical Systems), optical circuits and ASICs have been demonstrated. Packaging and integration processes have lagged behind MEMS research but are…

Modern cyber-physical systems are operated by complex software that increasingly takes over safety-critical functions. Software enables rapid iterations and continuous delivery of new functionality that meets the ever-changing expectations…

Critical software systems face stringent requirements in safety, security, and reliability due to the circumstances surrounding their operation. Safety and security have progressively gained importance over the years due to the integration…

Software system certification presents itself with many challenges, including the necessity to certify the system at the level of functional requirements, code and binary levels, the need to chase down run-time errors, and the need for…

Requirement engineering is a key ingredient for software development to be effective. Apart from the traditional software requirement which is not much appropriate for new emerging software such as smart handheld device based software. In…

Formal Methods are mathematically-based techniques for software design and engineering, which enable the unambiguous description of and reasoning about a system's behaviour. Autonomous systems use software to make decisions without human…

Software Engineering (SE) experiments are traditionally analyzed with statistical tests (e.g., t-tests, ANOVAs, etc.) that assume equally spread data across treatments (i.e., the homogeneity of variances assumption). Differences across…

Context: Continuous Software Engineering is increasingly adopted in highly regulated domains, raising the need for continuous compliance. Adherence to especially security regulations -- a major concern in highly regulated domains -- renders…

Concurrent software for engineering computations consists of multiple cooperating modules. The behavior of individual modules is described by means on state diagrams. In the paper, the constraints on state diagrams are proposed, allowing…

Software product line has emerged as a valuable concept of developing software based on reusable software assets. The concept aims on effective utilization of software assets, reduced time to delivery, improved quality and better benefits…

Recently, an increasingly growing number of companies is focusing on achieving self-driving systems towards SAE level 3 and higher. Such systems will have much more complex capabilities than today's advanced driver assistance systems (ADAS)…