Abstract
13485 Medical Device Quality Management System, specially designed for businesses operating in any area of the medical device manufacturing sector, helps identify and meet customer requirements, based on the problems in this sector. ISO 13485, which refers to the international standard, allows companies to have a corporate function, more flexible and useful services. At the same time, it is important for all companies in the medical equipment sector to integrate and implement this standard in order to act in accordance with the current legal regulations, to ensure quality products and services, to create customer satisfaction and to comply with all the EU norms. The Medical Device Directive defines the basic requirements for medical devices and equipment and defines the design, manufacture, placing on the market and supervision of these devices and their equipment, Keywords: Medical standards, consumer satisfaction, Device operation, system certification.
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