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One of the greatest challenges in software intensive systems such as safety critical systems is to ensure software quality assurance (called software assurance for brevity) which encompasses some quality-related attributes such as reliability and security as well as functionality and performance. To this end, engineers prefer a safety case or an assurance case, via Goal Structuring Notation (GSN)...
In the safety critical industries, the manufacturers should provide a compelling and comprehensible argument to demonstrate that their system is well designed so safety concerns either do not exist or can be negligible. These arguments are usually represented by an assurance case. However, one of challenging issues facing the safety critical industry is how to integrate an assurance case into manufacturers'...
Design a Safety critical system that satisfies all regulatory requirements is a challenging issue facing the software engineering community. In the medical systems industry, all medical devices must pass the FDA pre-market review before a new product can be deployed to the market because the FDA regulators need to ensure such new products are safe and reliable. Therefore, how to evaluate if a medical...
Safety critical systems emphasize the high quality of both hardware and software of a product since the safety of the product to the public tops all the other considerations. In these domains, regulatory agencies are entitled to conduct reviews on the entire range of artifacts produced from system design to system performance/maintenance. Regulatory review is comprised of the pre-market review and...
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