Applying Safety Case Pattern to Generate Assurance Cases for Safety-Critical Systems

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´ own development process. In this paper, we present how a safety case pattern which captures common structures of successful arguments can be applied as reusing strategies for building a new safety argument. More importantly, the latest development in Model Driven Engineering (MDE) facilitates the automatic integration of an assurance model into a development process. As a case study, we take the Generic Patient Controlled Analgesic (GPCA) Infusion Pump from the medical device industry into account to demonstrate how an assurance model can be generated in a development process via the safety pattern.