Medical device specificities: opportunities for a dedicated product development methodology

• Tipo: Outra Publicação em Revista Científica Internacional
• Data: 2012

Autores

Santos, ICT (Autor) Outra; Gazelle, GS (Autor) Outra; L.A. Rocha, E. Cretu and R.F. Wolffenbuttel (Autor) FEUP; João Manuel R. S. Tavares (Autor) FEUP

Revista

A Revista está pendente de validação pelos Serviços Administrativos.

Título: EXPERT REVIEW OF MEDICAL DEVICES

Vol. 9

Páginas: 299-311

ISSN: 1743-4440

Editora: Expert Reviews

Indexação

ISI Web of Knowledge - 14 Citações

Scopus - 25 Citações

Outras Informações

ID Authenticus: P-002-AA7

DOI: 10.1586/erd.12.3

Abstract (EN): The medical sector, similarly to other industries such 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, medical device 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

Nº de páginas: 13