Research On Quality Management Of New Product Introduction For TE Connectivity Medical BU

Medical Devices and Accessories Industry is a multidisciplinary cross,capital intensive and high technology industry.It mainly involves medicine,machinery,electronics and other technical fields.Its core technology covers medical polymer materials,laboratory medicine,hematology,life science,etc.The technology requirement and profit of medical devices and accessories are much higher than other industries,so,medical device and accessory industry is becoming the focus of competition in the world.With the development of science and technology and economy,the global demand for medical devices and accessories are driving rapidly by the people's living standard improvement,growth of population,the aging society and people's healthcare consciousness.The medical device and accessory manufacturers have increased the investment in the medical device and accessory research and development in order to provide competitive medical devices and accessories for different consumer groups and get more shares in the medical device and accessory industry.Therefore,how to ensure the quality of new product and shorten the lead-time of new product development is the key to continue maintain the competitiveness in the medical device and accessory industry.As most important part of the new product development and introduction,how to ensure the quality of new product and on time successfully launch to market during new product introduction need to be considered in the medical device and accessory manufacturing industry.In this paper,the author uses the New Product Introduction quality management process of TE Connectivity Medical BU Suzhou factory as the research object.Combining with the theory of project quality management,this paper studied the influence factors of the new product introduction process and project quality management based on the depth analysis of the new product introduction process in the Medical Device Accessory Industry.It builds a quality management system for the medical device accessory new product introduction by depth analysis of the quality control objects and reference standards at the stage of feasibility study,product and process development,verification and validation,industrialization(pilot run)and mass production.It also analyzes and summarizes the quality control processes used in each stage of medical device accessory new product introduction.Finally,this paper analyzes the quality assurance system of the medical device accessory during new product introduction through review the new product strategy,organizational structure,resource,new product introduction process and quality management system at TE Connectivity Medical Bu Asia Pacific.This paper summarizes the latest quality management system and implementation safeguards for medical device accessories new product introduction based on analyzes the current situation and existing problems of TE Connectivity medical device accessories new product introduction quality management.It creates the reference value on the project management practice for the new product introduction in the medical device accessory manufacturing industry.