Research On Quality Management Improvement Of New Product Development Of Y Company

With the development and progress of China’s economy and the gradual improvement of people’s health awareness,the medical device industry continues to expand and is one of the most dynamic industries at present.Both the society and users have put forward more and more requirements on the function,quality or service of medical devices,which plays a positive role in promoting the development of the industry and is both an opportunity and a challenge to the enterprises in the industry.In the field of medical devices,there are a variety of market segments,among which in vitro diagnostic products are an important one,and they play an important role in the public health emergencies caused by the novel coronavirus outbreak.In the face of emergencies,many excellent companies can quickly launch a product to meet the needs,which not only realizes the value of the company but also helps the social health cause.For medical devices,a competitive product not only needs to meet customer needs,but also to meet the regulatory requirements of medical devices.Its research and development process involves a number of activities,such as planning,verification,transfer,confirmation,risk management,clinical,registration and other internal and external activities.The scope of research and development of new medical device products and project management also involves the quality management requirements of research and development process.In recent years,many excellent enterprises in China have begun to realize the importance of quality management of research and development under the continuous exploration and practice.As mentioned above,due to the particularity of medical devices,national regulatory authorities are also constantly strengthening the update of laws and regulations and daily supervision of the multi-link research and development,production,and application of medical devices.The consensus in the industry is that quality is developed,not tested.This requires enterprises in the industry to improve their research and development management ability to meet the changing market environment,and constantly promote new products to the market to supply more high-quality products to meet customer needs and legal supervision.This paper takes the development quality management process of Y Company as the research object to discuss some problems in the four stages of new product development,including concept stage,planning stage,development stage and evaluation stage,covering process optimization,product risk management and organization definition and improvement.In terms of research methods,this paper mainly adopts the method of combining case analysis and interview,proposes the improvement plan according to the theory and method of quality management of new product development,and finally verifies the improvement plan in the project of B product.By analyzing and improving the quality management process of Y Company’s new product research and development,the quality management of Y Company’s research and development process and the manufacturability of its products are strengthened,the potential risks of products are reduced,and the regulatory compliance of medical devices products is improved.