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Context/Background: process and practice adoption is a key element in modern software process improvement initiatives, and many of them fail. Goal: this paper presents a preliminary version of a usability model for software development…
This paper presents the usability, acceptability and extent of compliance to ISO 25010:2011 of the developed project InFORMS. Key features that aid in the ease of use, access to, and management of the research resource emerged. From the…
With the recent advances in A.I. methodologies and their application to medical imaging, there has been an explosion of related research programs utilizing these techniques to produce state-of-the-art classification performance. Ultimately,…
Medical imaging AI development is fundamentally dependent on annotated datasets, yet no existing standard provides machine-enforceable validation across dataset structure, annotation provenance, quality documentation, and ML readiness…
In manufacturing, many use cases of Industry 4.0 require vendor-neutral and machine-readable information models to describe, implement and execute resource functions. Such models have been researched under the terms capabilities and skills.…
Context: The Internet of Things (IoT) has brought expectations for software inclusion in everyday objects. However, it has challenges and requires multidisciplinary technical knowledge involving different areas that should be combined to…
IEC 61131 has been widely accepted in the industrial automation domain. However, it is claimed that the standard does not address today the new requirements of complex industrial systems, which include among others, portability,…
Adapting security architectures to common standards like IEC 62443 or ISO 27000 in the Industrial Internet of Things (IIoT) involves complex processes and compliance reports. Automatic monitoring of compliance status would enhance this…
In the past years, software reverse engineering dealt with source code understanding. Nowadays, it is levered to software requirements abstract level, supported by feature model notations, language independent, and simpler than the source…
Increasing rate of progress in hardware and artificial intelligence (AI) solutions is enabling a range of software systems to be deployed closer to their users, increasing application of edge software system paradigms. Edge systems support…
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…
Background: The integration of the General Data Protection Regulation (GDPR) and the Medical Device Regulation (MDR) creates complexities in conducting Data Protection Impact Assessments (DPIAs) for medical devices. The adoption of…
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…
How do healthcare organizations (from small Practices to large HDOs) evaluate adherence to the cybersecurity and privacy protection of Medical Internet of Things (MIoT) used in clinical settings? This paper suggests an approach for such…
The ISO 21434 is a new standard that has been proposed to address the future challenges of automotive cybersecurity. This white paper takes a closer look at the ISO 21434 helping engineers to understand the ISO 21434 parts, the key…
Precision Medicine (PM) is an emerging approach that appears with the impression of changing the existing paradigm of medical practice. Recent advances in technological innovations and genetics, and the growing availability of health data…
Despite progress in vision-based inspection algorithms, real-world industrial challenges -- specifically in data availability, quality, and complex production requirements -- often remain under-addressed. We introduce the VISION Datasets, a…
Reliable product identification from images is a critical requirement in industrial and commercial applications, particularly in maintenance, procurement, and operational workflows where incorrect matches can lead to costly downstream…
Improving effectiveness and safety of patient care is an ultimate objective for medical cyber-physical systems. A recent study shows that the patients' death rate can be reduced by computerizing medical guidelines. Most existing medical…
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…