| With the development of economy and the increase of per capita GDP year by year,the quality of life of residents is not only measured by clothing,eating,residence and transportation,but also by medical care,which has become an indispensable part of life.With the continuous enhancement of residents’ awareness of medical care,the demand for medical device products is also growing.In recent years,the global medical device market is showing a trend of rapid growth.Compared with developed countries,industry of the Chinese medical device started late and accounted a relatively small for the global market of medical device.Although,market of the China’s medical device is also maintaining a high growth trend,but in the field of high-end medical devices,domestic medical device manufacturers are still at a significant disadvantage in the technical level.For example:CT tube,CT tube is the main equipment to generate X-ray,as the core component of medical CT machine,it is an extremely important and very expensive consumable product,it not only affects the quality of CT scanning imaging,but also determines the cost of CT machine.With the popularization of medical CT(X-ray computed tomography imaging technology),especially since the outbreak of COVID-19,CT scan imaging has been used as the main method to detect lung infection with SARS-COV-2 virus,which has achieved remarkable results in the epidemic prevention and control stage.Domestic CT bulbprocurement mainly depends on imports,at present,domestic CT bulb manufacturers still can not achieve the localization of CT tube.This paper takes Z Company as an example to analyze the quality management defects in the development project of CT tube products.Based on APQP(advanced product quality planning)concept,the application of a series of related quality management tools,so as to establish,improve a set of suitable for the development of CT tube product quality management system,is committed to improve the quality of products,reduce the cost of products,enhance the competitiveness of enterprises,and strive for the localization of CT tube. |
