Research On ISO 13485 Quality Management System Applied At Mingsing Company

Development of China medical devices industry can not do without the support of manufacturers in medical devices industry chain. Nowadays, Chinese medical devices industry especial small and medium enterprises are facing both opportunity of booming China medical devices market and challenge of other international competitors. Establishing and running ISO13485 quality management system provide a feasible solution to Chinese medical devices manufacturer who is in this essential period.Firstly, the thesis introduces development, basic theory and principle of quality management, and analyzed the relationship between ISO13485 technical specification and other quality standards. The thesis takes MingSing Company as an example, analyzes how the company establishes, runs, maintains and improves the ISO13485 quality management system. Mainly discusses CV7000's design, production, prototype detection, system assessment, declare registration processes in the system guidance.Eventually, author puts forward improvement suggestions to ISO13485 quality management system.The achievement: MingSing company has authorized by ZJFDA(ZHEJIANG Food and Drug Administration)and obtained the Registration Certificate For Medical Device...