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Research On The Supervision System Of Medical Device Industry Based On Internet

Posted on:2017-02-07Degree:MasterType:Thesis
Country:ChinaCandidate:K SunFull Text:PDF
GTID:2309330485479031Subject:Biomedical engineering
Abstract/Summary:PDF Full Text Request
The safety and effectiveness of medical devices are directly related to the health and safety of the public, which makes the supervision of medical devices have the characteristics of strong professional and high degree of attention. Medical device manufacturing enterprise is the source and foundation of the industry, and it is very important for the country and people to work on the supervision of medical device manufacturing enterprises and their products quality.Currently, and the EU, the United States, Japan and other developed countries and regions are using similar regulatory model, the risk and safety requirements of medical devices in accordance with the risk management model, in the face of the same situation, the regulatory product is similar to the regulatory product itself, but regulators are not only regulatory products itself, but also to face all kinds of people, even in the face of public quality differences and differences in public quality and national culture differences, leading to even more than two, although we use and European and American developed countries, even more than three. Is medical equipment manufacturing enterprises Industry production quality management level is low, operation of medical equipment quality management system is not smooth, medical device regulatory personnel capacity there is a big problem, four of the medical device manufacturing enterprise of missing the main responsibility, these problems has with the developed countries in Europe and the United States medical devices supervision tube problems facing the sector have little or nothing in common, to solve these problems by learning their regulatory model is ineffective, it is necessary to open a new path. The author tries to find out the contradiction between the supervision and management of medical devices, which is based on the characteristics of Internet thinking, open, fair, simple and efficient, which is used to solve the problems of the supervision and management of medical devices, which is based on the theory of game theory. It is a kind of exploration in the field of medical device supervision mode based on the combination of Internet thinking and medical device supervision.By improving the quality management of medical device production enterprises in the use of medical equipment, through the simulation test to improve the supervision of the ability to find problems in the process of inspection, through the regulatory authorities to guide enterprises to implement the main body responsibility, through the theory of game theory so that the regulatory authorities to choose the optimal regulatory strategy, and ultimately improve the effectiveness of medical devices, to achieve a multiplier effect..
Keywords/Search Tags:Internet, thinking mode, medical device supervision, production quality management standard, game theory
PDF Full Text Request
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