Utilización del AMFE y el DFC para la evaluación de los riesgos

Abstract

The medical devices Regulations require the establishment of an effective risk management program throughout product realization, conform to the provisions of harmonized standard NC ISO 14971. The aim of this paper is the evaluation of some advance quality techniques (Failure Mode and Effects Analysis - FMEA and Quality Function Deployment - QFD) for the medical devices hazard identification and risk estimation. For this propose, the risk assessment of an injectable and macroporous calcium phosphate bone cement, have been done. Biological tests, scientific papers and suitable standards were used for the risk assessment of the phosphate bone cement. Both techniques result very useful for risk assessment and identification of risk control measures, since the product design and development, to comply with medical device risk management requirements. © 2013 Springer.