Influence of the Quality Infrastructure in the Development of Medical Technologies

The national quality infrastructure is the result of the integration and coordination of several interrelated subjects: metrology, standardization, testing, accreditation, and certification. In this paper the impact of such infrastructure on the field of Cuban medical technologies and its present role as a technical tool for regulators are analyzed. The use of specific standards for medical technologies within the framework of risk and quality management systems, based on reliable measurements, is the basic infrastructure to guarantee the efficacy and minimize the risks of medical devices commercialized in the Cuban National Health System. Nevertheless, not all these elements are well established in the country. So, for the further development of the medical device sector a strengthening of the national quality infrastructure is indispensable.