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

Scientific software often presents very particular requirements regarding usability, which is often completely overlooked in this setting. As computational science has emerged as its own discipline, distinct from theoretical and…

Manufacturers of safety-critical systems must make the case that their product is sufficiently safe for public deployment. Much of this case often relies upon critical event outcomes from real-world testing, requiring manufacturers to be…

The use of machine learning systems in clinical routine is still hampered by the necessity of a medical device certification and/or by difficulty to implement these systems in a clinic's quality management system. In this context, the key…

Software Engineering Discipline is constantly achieving momentum from past two decades. In last decade, remarkable progress has been observed. New process models that are introduced from time to time in order to keep pace with…

Software metrics offer a quantitative basis for predicting the software development process. In this way, software quality can be improved very easily. Software quality should be achieved to satisfy the customer with decreasing the software…

Software is the main innovation driver in many different areas, like cloud services, autonomous driving, connected medical devices, and high-frequency trading. All these areas have in common that they require high dependability. In this…

The ubiquity of computing devices has led to an increased need to ensure not only that the applications deployed on them are correct with respect to their specifications, but also that the devices are used in an appropriate manner,…

Is the complexity of medical product (medicines and medical devices) regulation impacting innovation in the US? If so, how? Here, this question is investigated as follows: Various novel proxy metrics of regulation (FDA-issued guidelines)…

The management of data and digital assets poses various challenges, including the need to adhere to legal requirements with respect to personal data protection and copyright. Usage control technologies could be used by software platform…

Background: Research software plays an important role in solving real-life problems, empowering scientific innovations, and handling emergency situations. Therefore, the correctness and trustworthiness of research software are of absolute…

Medical training devices are becoming increasingly dependent on technology, creating opportunities that are inherently conducive to security breaches. Previous medical device research has focused on individual device security breaches and…

Although many attempts at automated aids for legal drafting have been made, they were based on the construction of a new tool, completely from scratch. This is at least curious, considering that a strong parallelism can be established…

The employment of micro-simulation (agent-based) tools in the phase of design of public and private spaces and facilities and for the definition of transport schemes that impact on pedestrian flows, thanks to their achieved accuracy and…

Computers may control safety-critical operations in machines having embedded software. This memoir proposes a regimen to verify such algorithms at prescribed levels of statistical confidence. The United States Department of Defense standard…

Ensuring the quality of automated driving systems is a major challenge the automotive industry is facing. In this context, quality defines the degree to which an object meets expectations and requirements. Especially, automated vehicles at…

Robotic systems are complex and safety-critical software systems. As such, they need to be tested thoroughly. Unfortunately, robot software is intrinsically hard to test compared to traditional software, mainly since the software needs to…

Since the early days of computers and programs, the process and outcomes of software development has been a minefield plagued with problems and failures, as much as the complexity and complication of software and its development has…

Scientific software applications are increasingly developed by large interdiscplinary teams operating on functional modules organized around a common software framework, which is capable of integrating new functional capabilities without…

One of the main issues of every business process is to be compliant with legal rules. This work presents a methodology to check in a semi-automated way the regulatory compliance of a business process. We analyse an e-Health hospital service…

Ensuring that autonomous space robot control software behaves as it should is crucial, particularly as software failure in space often equates to mission failure and could potentially endanger nearby astronauts and costly equipment. To…