Medical device specificities: opportunities for a dedicated product development methodology

• Type: Article in International Scientific Journal
• Date: 2012

Authors

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

Journal

Title: Expert Review of Medical Devices

Vol. 9 No. 3

Pages: 299-311

ISSN: 1743-4440

Publisher: Taylor & Francis

Indexing

ISI Web of Science

Scopus

COMPENDEX

Scientific classification

FOS: Engineering and technology > Other engineering and technologies

CORDIS: Technological sciences

Other information

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.

Language: English

Type (Professor's evaluation): Scientific