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The role of software in society has changed drastically since the start of the 21st century. Software can now partially or fully facilitate anything from diagnosis to treatment of a disease, regardless of whether it is psychological or…
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…
Safety and efficacy are the paramount objectives of medical device regulation. And in line with the medical ethos of non-maleficence, first do no harm, safety is the primary goal of regulation also. As such, risk management is the…
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…
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…
Background: Medical device development projects must follow proper directives and regulations to be able to market and sell the end-product in their respective territories. The regulations describe requirements that seem to be opposite to…
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…
Medical Artificial Intelligence (AI) involves the application of machine learning algorithms to biomedical datasets in order to improve medical practices. Products incorporating medical AI require certification before deployment in most…
Using machine learning in clinical practice poses hard requirements on explainability, reliability, replicability and robustness of these systems. Therefore, developing reliable software for monitoring critically ill patients requires close…
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…
An engineering design process may involve software modules that can executed concurrently. Concurrent modules can be very easily subject to some synchronization errors. This paper discusses verification process for such engineering…
Machine learning is expected to fuel significant improvements in medical care. To ensure that fundamental principles such as beneficence, respect for human autonomy, prevention of harm, justice, privacy, and transparency are respected,…
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.…
Advanced medical devices exploit the advantages of embedded software whose development is subject to compliance with stringent requirements of standardization and certification regimes due to the critical nature of such systems. This paper…
The ultimate goal in the pharmaceutical sector is product quality. However this quality can be altered by the use of a number of heterogeneous information systems with different business structures and concepts along the lifecycle of 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…
Cybersecurity issues in medical devices threaten patient safety and can cause harm if exploited. Standards and regulations therefore require vendors of such devices to provide an assessment of the cybersecurity risks as well as a…
Software measurement programs have emerged as compounds of several measurement activities that are pursued as part of a combined effort of several parties within a software organization, based on interests that the organization has…
Purpose: The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in-vitro diagnostics (IVD),…
As wearable health technologies have grown more sophisticated, the distinction between "wellness" and "medical" devices has become increasingly blurred. While some features undergo formal U.S. Food and Drug Administration (FDA) review, many…