Quality Assurance in Production of Medical Devices

摘要

An introducing and development of the quality system at any production or service is necessary assumption to be prosperous in opened market. Special attention has to be devoted to tasks of the quality of medical devices production, because an incidental use of the technical of poor quality product, can be cause of the health loss or can directly to endanger the users life. Very strict demands on quality level and its reproduction of the medical appliances must be respected by some peculiarities at introducing of the quality systems as well. A producer is obliged to eliminate or minimize all risks connected with use of the medical devices, namely by their correct design, selection of the materials and manufacturing process. That is why the complex risk analyze has to be performed as inseparable part of the conformity assessment procedure. Some our practical knowledge and experiences with introducing, development and inspection of the quality system at small producer of the medical devices are written in this paper. Mentioned realities are introduced on example of the manufacturing of the two types of magnetotherapeutic devices.