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Manufacturing of medical devices is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a medical device is being marketed for use. In general, these requirements make no…
The integration of medical devices in the patient treatment process becomes increasingly important due to the efficiency of the technology. On the one hand, medical devices hardware is more powerful and its integration with the software…
The medical device products at the European Union market must be safe and effective. To ensure this, medical device manufacturers must comply to the new regulatory requirements brought by the Medical Device Regulation (MDR) and the In Vitro…
Despite the immense potential of AI-powered medical devices to revolutionize healthcare, concerns regarding their safety in life-critical applications remain. While the European regulatory framework provides a comprehensive approach to…
The use of embedded software is advancing in modern medical devices, so does its capabilities and complexity. This paradigm shift brings many challenges such as an increased rate of medical device failures due to software faults. In this…
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…
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…
A key mission of computer science is to enable people realize their creative ideas as naturally and painlessly as possible. Software engineering is at the center of this mission -- software technologies enable reification of ideas into…
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…
Modern software has been an integral part of everyday activities in many disciplines and application contexts. Introducing intelligent automation by leveraging artificial intelligence (AI) led to break-throughs in many fields. The…
Usually, it is the software manufacturer who employs verification or testing to ensure that the software embedded in a device meets its main objectives. However, these days we are confronted with the situation that economical or…
Software has gained immense importance in our everyday lifeand is handling each and every aspect of today's technologicalworld. The idea of software at initial phase was implemented bya very precise minority of individual and now it's…
Software is a unique entity that has laid a strong impact on all other fields either related or not related to software. These include medical, scientific, business, educational, defence, transport, telecommunication to name a few.…
Medical robotics includes assistive devices used by the physician in order to make his/her diagnostic or therapeutic practices easier and more efficient. This chapter focuses on such systems. It introduces the general field of…
Medical devices and artificial intelligence systems rapidly transform healthcare provisions. At the same time, due to their nature, AI in or as medical devices might get exposed to cyberattacks, leading to patient safety and security risks.…
Design is a fundamental aspect of engineering, enabling the creation of products, systems, and organizations to meet societal and/or business needs. However, the absence of a scientific foundation in design often results in subjective…
Software now lies at the heart of scholarly research. Here we argue that as well as being important from a methodological perspective, software should, in many instances, be recognised as an output of research, equivalent to an academic…
Within the healthcare environment, mobile health (mHealth) applications (apps) are more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the Covid-19 pandemic has led to an enormous amount…
Aim: provide a methodological framework for the process of clinical tests, clinical acceptance, and scientific assessment of algorithms and software based on the artificial intelligence (AI) technologies. Clinical tests are considered as a…
Over the last decade, surgical robots have risen in prominence and usage. For surgical robots, connectivity is necessary to accept software updates, accept instructions, and transfer sensory data, but it also exposes the robot to…