Study On The Improvement Of Product Quality Control Measures Of R Medical Device Company

Since the 21 st century,the medical device industry has developed vigorously in China,and China’s medical device market has grown rapidly.However,behind the geometric growth of the industry,the unstable product quality and product performance cannot be compared to the industrial pain points of imported products from Europe and the United States,which restricts the pace of the medical device industry to further occupy the global market.With the implementation of the national strategy of "Made in China 2025" to build a manufacturing power,under the guidance of the basic policy of "quality first",domestic enterprises must effectively improve the quality control level of their products and take the development path of winning by quality.In the analysis of this paper,Company R was selected to carry out a case study to find a new way to improve product quality control of medical device enterprises.Based on the collected literature and domestic and international research,and in conjunction with the requirements of the ISO 13485 international standard for medical devices and the Chinese medical device regulations and standards,this paper carries out an in-depth evaluation and analysis of Company R’s product quality control.The main elements are as follows.Firstly,for the ISO 13485 standard,an introduction is made in terms of its structure,and the basic idea is clarified and the significance of this standard is explained.Furthermore,an introduction is made from the background of the Code of Practice for Quality Control in the Production of Medical Devices,and the significance of the introduction of this code is explained,as well as the links that exist with the ISO 13485 standard.The strategy for medical device companies to establish a quality control measures in combination with the requirements of these two aspects is gradually developed and the corresponding steps are formulated.Next,the quality control system of company R is analyzed to understand its current operational status and to analysis the factors influencing the quality control measures of company.Based on the two requirements mentioned earlier,it is pointed out that when constructing the quality control evaluation index system,Company R must select "management responsibility","resource management","product realization","measurement,analysis and improvement",and "quality management system".The four target layers of "measurement,analysis and improvement" were used to establish a reasonable and comprehensive quality control evaluation index system for Company R by refining the composition of each factor layer under them.Finally,a questionnaire survey was conducted to allow the personnel of Company R to score the outstanding indicators that have a greater impact on the company’s quality control measures,and the evaluation results were analyzed to give an effective strategy for improving the quality control measures of the company.