The Improvement Of Quality Management For Product X’s Research And Development

With the development of the world economy, science and technology, human to meet theincreasing material and spiritual needs at the same time, more and more attention to theirhealth, more and more resources to the medical service industry. In recent decades the humanfound only rely on drugs cannot cope with various disease research, diagnosis, prevention,monitoring, treatment and replacing human tissue, support or sustain life, and medicalequipment and began to develop rapidly. From scratch, continuous improvement, medicalequipment and product characteristics are not as same as other products requirements-safety,effective. This also means that the medical device quality management focuses on the productdesign and development stage. Good quality management in medical device product designand development stage, the future product manufacturing, sales, market, use and recyclingprocess plays a decisive role, to improve the economic efficiency of enterprises, to predict,control risk in manufacturing, sales, product use process, reduce the harm to patients.Y medical technology company was founded in1996, with product design and excellentquality control team in10years of operation, has accumulated some design and developmentand quality management experience, with more than a dozen patents and practical appearancepatent, the enterprise is in the domestic same industry leading enterprises, participate in theformulation of a number of National standards.This paper will use the case study approach, to the quality management of Y company Xproduct design and development projects as the research object, introduces the quality controlplan, risk management, process validation, quality function deployment, measures and toolsimprovement, describe the X medical equipment products in the situation and process designand development stage of quality management, the problems and the analysis of qualitymanagement of X product design and development, quality management of product designand development and puts forward the improvement measures and the results were comparedbefore and after improvement.In this paper, the problems of quality management of X product design and developmentanalysis and put forward the improvement measures, has important meaning for the designand development of quality management ability, Y improvement and continuous improvement,but also provide a reference and reference for the design and development of other company quality management of medical devices industry of new products.