The Quality Improvement Of "V" Design Control Based On "C" Company

With the growth of the world economy and the development of science and technology,human beings are paying more and more attention to their health while meeting the increasing material and spiritual needs.More and more resources are invested in the medical service industry,such as public hospitals,private medical institutions,medical research institutions,as well as special sanatoriums and nursing homes.The demand and quantity of medical devices in this huge market could be expected.In recent decades,medical devices began to appear and continue to improve rapidly,the demand and requirements of major medical institutions for medical devices are increasingly high,of course,the quality is also the top priority of concern.Moreover,medical devices have the same product characteristics as other products,that is,safe and effective.This means that the focus of the quality management of medical devices is in the stage of product design and development.In the early stage of design and development to do a good job in the preparation of quality management,the production of products,sales and use of follow-up behavior has a decisive significance and role,because medical devices are directly in contact with patients and produce diagnosis or treatment.Therefore,the quality of the products should be controlled by systematic and comprehensive quality management methods as soon as possible so as to ensure that the quality of the products can meet the needs of market competition,help enterprises to achieve good economic benefits under new opportunities and competition,and effectively control the risks of the products in the whole life cycle,ensures the safety of patients.As the example of C company whose mainly product is Oxygen Concentrator,this paper studies the current situation of quality management in the design and development of medical equipment projects at home and abroad.Starting from the main ideas and concepts of quality management and combining with the historical development background of C Company,this paper investigates and analyzes the current situation and existing problems of quality system management in C Company.From the aspects of quality control,risk management and quality management system documentation and personnel training,this paper puts forward the ideas and Countermeasures of improving the design and development process of V product of oxygen making machine,hoping to improve the overall quality goal of V project design by establishing quality control process system and process control system,and through the initial stage of project establishment.This paper introduces risk management,defines risk management team and uses analysis and evaluation tools to identify risks,implement measures and means to reduce risks,provide staff quality awareness through strengthening training and assessment mechanisms,create a quality culture to publicize the quality of the enterprise to people to participate in quality activities and other links to continuously improve C company.The overall quality management system level.And ultimately help C company successfully obtain the relevant product license approval of the target market.The final result is that C company has successfully obtained the license and listing license of medical devices in target countries and regions,which convincingly proves that the steps and methods used in V project design and development are effective and feasible.This method is retained for reference and reference for the development of other products.