Desenvolvimento de Software para Dispositivos Médicos: Uma Abordagem Ágil

• Autor(a) principal: Manuel José Leal Zamith de Passos
• Data de Publicação: 2018
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: https://hdl.handle.net/10216/114264
• topic: Engenharia electrotécnica, electrónica e informática; Electrical engineering, Electronic engineering, Information engineering

Regulation of medical devices has been one of the most prominent initiatives of the European Union in the health domain. The recent Medical Device Regulation 2017/745/EEC extended the definition of medical devices to standalone software systems with prognostic and prevision intended purposes. This paradigm shift stimulates the development of more lightweight software systems such as mobile applications, that can be classified as legitimate medical devices and can be prescribed to patients. This new context creates the need for an urgent adjustment of the currently used software development life cycle models and processes. Aditionally, agile development offers a lightweight framework for helping teams maintain a focus on the rapid delivery of business value. As a result of this focus, the benefits of agile software development are that organizations are capable of significantly reducing the overall risk associated with software development, given a constantly evolving functional and technical landscape. This dissertation discusses a tailored agile approach based on the SCRUM model, designed to be compliant with the international standards for medical device software development and benefit the creation of software solutions according to the current Medical Device Framework. The discussion in this paper demonstrates there is no reason to believe that agile methodologies should not benefit the process of creating software solutions in the medical device domain. These conclusions were supported by professionals in the software development industry with experience working in critical systems, as well as qualified individuals working in the medical device field.