Medical device specificities: opportunities for a dedicated product development methodology

• Type: Another Publication in an International Scientific Journal
• Date: 2012

Authors

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

Journal

The Journal is awaiting validation by the Administrative Services.

Title: EXPERT REVIEW OF MEDICAL DEVICES

Vol. 9

Pages: 299-311

ISSN: 1743-4440

Publisher: Expert Reviews

Indexing

ISI Web of Knowledge - 14 Citations

Scopus - 25 Citations

Other information

Authenticus ID: 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.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 13