Medical device specificities: opportunities for a dedicated product development methodology.
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.
Instituto de Engenharia Mecânica e Gestão Industrial, Faculdade de Engenharia, Universidade do Porto, Porto, Portugal.
Isa C T
IC
Santos
G Scott
GS
Gazelle
Luís A
LA
Rocha
João Manuel R S
JM
Tavares
D018795:Device Approval; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies; D005060:Europe; D005062:European Union; D006801:Humans; D007221:Industry / Q000592:standards; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards