Aplikace nástrojů managementu kvality při zajišťování použitelnosti zdravotnických prostředků

Abstract

The aim of the thesis was to design a methodology for the process of determining the applicability of medical devices. The subsequent application of the proposed methodology to the particular product has been added to the method of QFD. Particular product was a digital colposcope, which is part of the gynecological chair Gracie. Implementation took place at Borcad cz s. r. o. was first developed the theoretical basis of tackle. In determining the applicability of medical devices were analyzed by the standards. For the application of QFD method was discussed in detail quality planning. The following section describes the current state determination of suitability of medical devices in the company Borcad cz s. r. o. Subsequently a methodology for determining the usability of medical devices. Then there was the application of this methodology on the product. The application was accompanied by QFD, which were first identified customer requirements and was assigned a weight. Furthermore, the proposed quality characteristics of the product and the importance of the individual characters. He was subsequently constructed "House of Quality.” Then they were designed to target values , which are the main result of the "House of Quality."