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

Software security has been an important research topic over the years. The community has proposed processes and tools for secure software development and security analysis. However, a significant number of vulnerabilities remains in…

Embedded systems are ubiquitous and play critical roles in management systems for industry and transport. Software failures in these domains may lead to loss of production or even loss of life, so the software in these systems needs to be…

Currently, software industries are using different SDLC (software development life cycle) models which are designed for specific purposes. The use of technology is booming in every perspective of life and the software behind the technology…

Internal software quality determines the maintainability of the software product and influences the quality in use. There is a plethora of metrics which purport to measure the internal quality of software, and these metrics are offered by…

The safety and clinical effectiveness of medical devices are closely associated with their specific use in clinical treatments. Assuring safety and the desired clinical effectiveness is challenging. Different people may react differently to…

Wearable devices are a new form of mobile computer system that provides exclusive and user-personalized services. Wearable devices bring new issues and challenges to computer science and technology. This paper summarizes the development…

Software testing has received much attention over the last years and has reached such critical importance that agile software development practices put software testing at its core. Agile software development is successfully applied in…

Processing regulations and resulting requirements to achieve regulatory compliance in software engineering (SE) is a developing challenge due to the continuously growing amount, complexity, and expanding scope of regulations. Despite the…

Artificial Intelligence (AI) and Machine-Learning (ML) models have been increasingly used in medical products, such as medical device software. General considerations on the statistical aspects for the evaluation of AI/ML-enabled medical…

This paper describes a set of tools for automating and controlling the development and maintenance of software systems. The mental model is a software assembly line. Program design and construction take place at individual programmer…

Over the last several decades, computer games started to have a significant impact on society. However, although a computer game is a type of software, the process to conceptualize, produce and deliver a game could involve unusual features.…

Changes, they use to say, are the only constant in life. Everything changes rapidly around us, and more and more key to survival is the ability to rapidly adapt to changes. This consideration applies to many aspects of our lives. Strangely…

Connected Medical Devices (CMDs) have a large impact on patients as they allow them to lead a more normal life. Any malfunction could not only remove the health benefits the CMDs provide, they could also cause further harm to the patient.…

While procedures prevail on the European market for the greater good of its citizens, it might be daunting when trying to introduce a product, whether innovative or not. In the current world, Cyber-Physical Systems (CPSs) are ubiquitous in…

Modern society is increasingly surrounded by, and accustomed to, a wide range of Cyber-Physical Systems (CPS), Internet-of-Things (IoT), and smart devices. They often perform safety-critical functions, e.g., personal medical devices,…

Software testing is a critical element of software quality assurance and represents the ultimate review of specification, design and coding. Software testing is the process of testing the functionality and correctness of software by running…

Artificial intelligence (AI) in medical device software (MDSW) represents a transformative clinical technology, attracting increasing attention within both the medical community and the regulators. In this study, we leverage a data-driven…

The requirements in automation, digitalization, and fast computations have loaded the IT sector with expectations of highly reliable, efficient, and cost-effective software. Given that the process of testing, verification, and validation of…

[Context and motivation] When developing software, coordination between different organizational units is essential in order to develop a good quality product, on time and within budget. Particularly, the synchronization between…

Continuous software engineering has become commonplace in numerous fields. However, in regulating intensive sectors, where additional concerns needs to be taken into account, it is often considered difficult to apply continuous development…