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Lopes, Karyn Martinelli; Zancul, Eduardo de Senzi;


The aim of the article is to present the requirements for a PDP reference model for medical devices. The methodological approach selected is a case study of six medical devices projects, carried out at the research group in which this article is inserted. The results of theoretical and empirical research show the initial requirements and the importance of regulatory issues. The projects analyzed employed the Biodesign approach. However, it is still necessary to improve the research about the requirements and medical devices development in Brazil. This article is part of a broader research that aims to develop a specific PDP reference model for the health sector.


Palavras-chave: PDP reference model, Medical devices, Biodesign,


DOI: 10.5151/cbgdp2017-027

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Como citar:

Lopes, Karyn Martinelli; Zancul, Eduardo de Senzi; "REQUIREMENTS IDENTIFICATION FOR A PDP REFERENCE MODEL FOR MEDICAL DEVICES", p. 262-270 . In: . São Paulo: Blucher, 2017.
ISSN 2318-6968, DOI 10.5151/cbgdp2017-027

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