Medical device specificities: opportunities for a dedicated product development methodology

• Tipo: Artigo em Revista Científica Internacional
• Data: 2012

Autores

Isa C. T. Santos (Autor) FEUP; G. Scott Gazelle (Autor) Outra; Luís A. Rocha (Autor) Outra; João Manuel R. S Tavares (Autor) FEUP

Revista

Título: Expert Review of Medical Devices

Vol. 9 Nº 3

Páginas: 299-311

ISSN: 1743-4440

Editora: Taylor & Francis

Indexação

ISI Web of Science

Scopus

COMPENDEX

Classificação Científica

FOS: Ciências da engenharia e tecnologias > Outras ciências da engenharia e tecnologias

CORDIS: Ciências Tecnológicas

Outras Informações

DOI: 10.1586/ERD.12.3

Abstract (EN): 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 product¿s 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 device¿s specificities are identified and the most relevant legislation is reviewed providing the foundations for a dedicated product development methodology.

Idioma: Inglês

Tipo (Avaliação Docente): Científica