Company A Quality Management Research Of Medical Device New Product Development Project

The medical Antisepsis and sterilization products is high quality risk product,due to the particularity of its products,in the new product development process,the verification process should not only meet the requirements of laws and regulations in domestic and different nations and regions,guarantee quality stability,but also from the perspective of customers to understand customer requirements.New product development and validation determines the success or failure of the project,and even affect the medical device manufacturing enterprise's reputation and survival.Therefore,how to regulate the effective management of medical industry new product project is particularly important.According to the previous project quality management experience and lessons,if no effective method system in the whole process of new product development management,any deviation during the project implementation,the organization will fall into a passive situation and impact on the enterprise market development and investment decision,as well as regulatory risk.The study of this paper combined with the actual situation of domestic and foreign medical products manufacturing enterprises,focusing on how to use the product and process understanding(PPU)principles which A company implemented for the development,management system and control the quality management of medical sterilization new products validation process.Firstly,this paper analyzes the common methods of new medical device validation.Secondly,analyze the issue of quality management in A company medical device new product development.Thirdly,based on Product and process understanding(PPU)method and idea,focus on customer need,raise quality management improvement strategy to medical device new product development project.Finally,in the case of the AVA product series,discuss the application process of the quality management improved strategy in detail,and analyze the application effect.