UML profiling for software systems in medical device manufacturing

Abstract

Quality is a major concern in Medical Device Manufacturing (MDM). Conformance with prevailing regulatory standards is of profound importance in MDM. Due to critical nature and dependability of the domain, development of Workflow management information systems (WMIS) that truly depict the domain concepts along with the associated quality and regulatory parameters could be a challenging task. A Medical Device (MD) is not considered acceptable unless a documented conformance evidence is provided which supports the adequacy of the medical product to be used for its intended purpose. Therefore, WMIS for these manufacturing setups must provide an argumentative linkage between the development processes and corresponding regulatory requirements. In this paper, we have proposed a UML Profile Architecture for development of WMIS for medical device manufacturing setups. A case study from MD industry is included to discuss the benefit and applicability of the proposed methodology in detail.