6-Sigma Technique Application On Medical Device New Product Validation

Medical product is high risk product, due to the product nature, not only the stable product quality is required, also the all the process need to comply with series of international and national regulations. The question of how to effective manage the new product quality with compliance to regulation became a critical issue to the manufacturer profitability. Simply, the answer will lie in the lack of systematic idea in the whole quality management process, the effective management method and approach need to be formed. So, any deviation during the project implementation can bring the organization into a passive situation and impact the company market exploration and investment decision, as well as the regulatory risk.The study of this article will base on international and domestic medical device manufacturer practice, focus on how to apply 6 Sigma technique to systematic develop, manage and control the quality in the new medical product validation. Thesis analyzed general model and approach of new medical device validation and the limitation of traditional quality management application on validation. Discussed the feasibility, advantage and limitation of 6 Sigma technique application on new medical device product validation. The application detail of 6 Sigma to validation also has been described: clarify project objective and requirement, measurement and control system analysis and evaluation, Key Process Input Variable analysis, system input and output relation, process window screen out and optimization and long term process capability sustain and control. Illustrate how to organic integrate 6 Sigma technique and medical device validation, put forward the management approach and content of the 5 phase of validation, and finally generate a systematic and effective preventive quality management model which through controlling Key Process Input Variable to achieve desired process output.Base on the theoretical study, the thesis also cited an actual case of 6 Sigma technique application on new medical device validation, describe the application process with further detail, and this will provide a better precondition and base for the study result popularization.