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Author(s): Isa C. T. Santos
G. Scott Gazelle
Luís A. Rocha
João Manuel R. S Tavares
Title: Medical device specificities: opportunities for a dedicated product development methodology
Issue Date: 2012
Abstract: The medical sector, similarly to other industries as the aviation industry, has to comply with multiple regulations, guidelines and standards. In addition, there are multiple definitions for the expression medical device and, before entering the market, manufacturers must demonstrate their products safety and effectiveness. In such a complex and demanding environment it is crucial to know the particularities surrounding the product being developed in order to minimize the chances of a commercial flop. Thus, in this paper, the medical devices specificities are identified and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology.
Subject: Ciências Tecnológicas, Outras ciências da engenharia e tecnologias
Technological sciences, Other engineering and technologies
Scientific areas: Ciências da engenharia e tecnologias::Outras ciências da engenharia e tecnologias
Engineering and technology::Other engineering and technologies
Document Type: Artigo em Revista Científica Internacional
Rights: restrictedAccess
Appears in Collections:FEUP - Artigo em Revista Científica Internacional

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