V Congreso Latinoamericano de Ingeniería Biomédica (CLAIB2011)

Utilización del AMFE y el DFC para la Evaluación de los Riesgos
Guerra Bretaña Rosa Mayelin, Meizoso Valdés María del carmen, Almirall La Serna Amisel

Última modificación: 2011-04-16 08:00


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.