Um modelo de decomposição de requisitos de segurança para projetos na indústria de dispositivos médicos

Abstract

Towards the development of medical device‟s industry, making products with quality and safety is the main goal in an attempt to avoid serious harms to the patient, operator or environment. For this reason, engineers involved on development process need increasingly commitment with efficient analysis techniques, projects and deployments in a consistent way to have reliable devices. Nowadays, industry and academics have been providing evidences that traceability between elements of projects are one of the main causes of: (i) non-certification of safety-critical devices, and (ii) catastrophic failures. Unfortunately, engineers have been using traceability approaches without planning. In practice, maintaining traceability between elements is a difficult task, as requirements can change and types of elements can be different, turning a project into a mixture of types of elements. Thus, maintaining traceability is a big challenge. In this work, it is proposed an extension of Antonino and Trapp‟s work – Improving Consistency Checks Between Safety Concepts and View Based Architecture Design – making a safety requirement decomposition model focused on a medical devices‟ industry, in which it was added one more level to represent a prior risk analysis, expected for the regulation standards of this industry (such as ISO 14971:2007 and the IEC 62304:2006), up to system architectural elements. In addition to that, it was presented an Enterprise Architect add-in that will perform model verifications in order to assure that the concerns of the model decomposition will be followed. This is an explored research, which has been developed at the Center for Strategic Technologies in Health with a Fraunhofer-IESE‟s collaboration.