Research And Development Quality Management Studied On Medical Electrical Device

Since the beginning of the21st century, China’s medical devices industry is booming. As we know, medical electronics device industry is a high-risk products, due to the particularity of the background of its products must have good reliability and stability. It determines the products in the development stage shall have good quality management methods and tools to manage and control the development of product quality.This paper will base on international and domestic research and development enterprise, especially in domestic and international medical electronics device manufacturer, combined with my experiences in R&D enterprise quality testing in past years and made the following detail and depth analysis.Firstly, the paper compared the process similarities and differences of the general R&D projects and the R&D projects of medical electronic devices and analyzes the characteristics. By the process, the paper will use the application of quality management theory methods and tools based on the different stages.Secondly, the paper studies on the first phase of the R&D process-product definition, analysis of the quality function deployment (QFD) theory. And analysis of customer needs into demand for R&D projects through the House of Quality.Moreover, the paper studies on the second phase of the R&D process-product design and research. in the study to determine exposure parameters automatically by the Taguchi experiment design method and on the basis of the feasible set, based on Taguchi method to design the automatic exposure parameter design theory, and through parameter optimization design parameters, to help improve the quality of product research and development.Lastly, the paper study on the third phase of the R&D process-product verify and validation testing. Introduces the medical electrical products function test model and method, function test evaluation process and method of reliability growth test and so on. Another test of risk management and countermeasures are introduced.