During the past two decades, there has been an explosive volume of software applied in the field of heath care. As medical software becomes pervasive in all facets of health care services, the risk of software related patient injuries and patient deaths is also on the rise. To assure the quality of medical software, rigorous validation and verification methods must be employed to analyze all phases of development and final products. In this thesis, a systematic review was conducted to examine and summarize research in the area of medical software certification, which is the primary quality assurance approach taken by regulatory bodies. Key findings indicate that research in the field of medical software certification is sparse, with a limited range of focus and research methodologies. Greater effort using empirical research approaches is necessary for the improvement of current research in medical software certification. / Graduate

[pt] A presente dissertação avalia um software médico através de parâmetros e critérios ergonômicos. Primeiramente descrevem- se os conceitos relativos a Tecnologia da Informação e conceitua-se o software como um dos subsistemas de qualquer sistema de Tecnologia da Informação. A partir de então, verificou-se as etapas de desenvolvimento de software, relacionados ao contexto de usabilidade. Levantaram-se também os principais problemas de interação encontrados no software. A segunda parte da pesquisa, um estudo de caso, inclui a realização de heurística, entrevistas, grupo de foco e técnica de eliciação do conhecimento (card sorting), para que os usuários pudessem expressar sua opinião com relação ao software, às dificuldades encontradas e à utilização de menus. / [en] This thesis evaluates a medical software according to ergonomic criteria and parameters. Firstly, the concepts related to Information technology were described and the software was defined as one of the subsystems together whith the presentation of Information Technology. After that, the stages of software design were determined: context of usability. The main problems related to software interfaces were also described. The second part of this research, a case study, included heuristic approach, interview, focus groups and a knowledge elicitation (card sorting). So that users would have the opportunity to express their opinions in relation to the difficulties faced with its use.

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