Aproximación a la norma NC ISO 13485:2005 para la gestión de la calidad en equipos médicos

Abstract

The medical equipment field is heavily regulated. Given the nature, it has been essential to formulate special rules that support the implementation of quality systems in design, production and marketing for these technologies. The global trend is increasing to implement and certify quality management systems (QMS) based on the specific standard for this sector. However in this moment, Cuba has not any organizations certificates related to the NC ISO 13485:2005 specialty. The NC ISO 13485:2005 standard is a new challenge for the Cuban manufacturers given the renewed demands from the National Control Centre of Medical Equipment and the international trend. Therefore, to study its content and scope in depth is a necessity. Apply as appropriate and consistent these regulations to satisfy all interested parties and work on improving the institutional performance is imperative for all entities related to this complex sector. The work aims to approach this standard analysing theoretical and relevance aspects, the current scenario and trends associated with its implementation as well as elements to be considered for their adaptation in the Cuban context, in order to shorten gaps between manufacturers and regulatory agencies for an effective implementation. © 2013 Springer.