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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…
The design of low-power wearables for the biomedical domain has received a lot of attention in recent decades, as technological advances in chip manufacturing have allowed real-time monitoring of patients using low-complexity ML within the…
Nowadays, we are rapidly moving beyond bespoke detailed solutions tailored for very specific problems, and we already build upon reusable and more general purpose infrastructures and tools, referring to them as IoT, Industrial IoT/Industry…
ISO 14971 is the primary standard used for medical device risk management. While it specifies the requirements for medical device risk management, it does not specify a particular method for performing risk management. Hence, medical device…
Increasing automation and external connectivity in industrial control systems (ICS) demand a greater emphasis on software-level communication security. In this article, we propose a secure-by-design development method for building ICS…
Recent Artificial Intelligence (AI) models have matched or exceeded human experts in several benchmarks of biomedical task performance, but surgical benchmarks in particular are often missing from prominent medical benchmark suites. Since…
Research software is essential to modern science, yet many research-performing organisations lack coherent policies to support its development, sustainability, and recognition. Despite its central role in research outcomes, research…
Prognostic and diagnostic AI-based medical devices hold immense promise for advancing healthcare, yet their rapid development has outpaced the establishment of appropriate validation methods. Existing approaches often fall short in…
The popularity and wide spread of IoT technology has brought about a rich hardware infrastructure over which it is possible to run powerful applications that were not previously imagined. Among this infrastructure, there are the medical…
As AI-enabled software systems become more prevalent in smart manufacturing, their role shifts from a reactive to a proactive one that provides context-specific support to machine operators. In the context of an international research…
Ontologies serve as a one of the formal means to represent and model knowledge in computer science, electrical engineering, system engineering and other related disciplines. Ontologies within requirements engineering may be used for formal…
Business process modeling is used by most organizations as an essential framework for ensuring efficiency and effectiveness of the work and workflow performed by its employees and for ensuring the alignment of such work with its strategic…
[Context and motivation]: Understanding and interpreting regulatory norms and inferring software requirements from them is a critical step towards regulatory compliance, a matter of significant importance in various industrial sectors.…
Actually Information security becomes a very important part for the organization's intangible assets, so level of confidence and stakeholder trusted are performance indicator as successes organization. Since information security has a very…
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),…
The ISO 26262 standard from 2016 represents the state of the art for a safety-guided development of safety-critical electric/electronic vehicle systems. These vehicle systems include advanced driver assistance systems and vehicle guidance…
In the process industry, the configuration of Safety Instrumented Systems (SIS) must comply with a defined set of safety requirements, typically documented in the Safety Requirements Specification (SRS). The functional safety standard IEC…
Large language models (LLMs) show significant potential in healthcare, prompting numerous benchmarks to evaluate their capabilities. However, concerns persist regarding the reliability of these benchmarks, which often lack clinical…
Software applications often pose barriers for users with accessibility needs, e.g., visual impairments. Model-driven engineering (MDE), with its systematic nature of code derivation, offers systematic methods to integrate accessibility…
As the performance of large language models (LLMs) continues to advance, their adoption in the medical domain is increasing. However, most existing risk evaluations largely focused on general safety benchmarks. In the medical applications,…