II ABSTRACT With development of domestic medical device industry, opportunities and crises coexist in the Chinese medical device market. On the one hand, the market demand for medical devices is huge, on the other hand, the fierce competition has brought greater competitive pressure and even survival pressure to the medical device enterprises. As a multinational company, G company, which entered the Chinese market earlier, has always been in the forefront of the industry in the market share of domestic medical devices. In recent years, it has to face not only the encroachment of domestic medical device enterprises on the low-end product market they occupy, but also the extrusion of other well-known multinational medical device enterprises on the high-end product market they occupy. In order to alleviate the pressure of enterprise survival and seek growth point, G company is also actively adjusting its product strategy. After years of promoting localization and optimizing the potential of product design, it began to turn its attention to outsourcing some products. Based on this background, this study uses empirical research methods to explore the outsourcing risk evaluation and management ideas of representative product a of G company. Based on the review of outsourcing theory and outsourcing risk management research at home and abroad, this paper analyzes the current situation and problems of a product of G company, and selects the matching outsourcing mode - joint design and manufacturing outsourcing. Based on the analysis of the corresponding outsourcing mode and the influencing factors of outsourcing risk, the risk evaluation index system and risk evaluation model are established. The model is applied to evaluate the outsourcing risk of product a, and the conclusion that the comprehensive score of outsourcing risk of product a is low risk is obtained. The risk matrix is used to analyze the evaluation results, and the conclusion is drawn that in all the risk impacts, more attention should be paid to the supplier's performance risk, information disclosure risk and outsourcing contract default risk. At the same time, based on the analysis results, a systematic risk management and control method is proposed. From the perspective of industry practitioners, this paper fully analyzes the source and influencing factors of outsourcing risk in medical device industry, selects risk evaluation indicators that fit the characteristics of the industry, establishes a set of evaluation model for industry reference by using risk matrix method, demonstrates the specific application of risk evaluation model by taking product a of company G as an example, and puts forward systematic risk management methods. The above outsourcing risk assessment and risk management methods can provide certain theoretical and practical reference for medical device enterprises to make outsourcing business decision and outsourcing risk management. There are 18 Charts，26 tables and 39 references. KEYWORDS: Medical Devices; Outsourcing; Risk Management; Risk Matrix; 北京交通大学硕士专业学位论文 目录 III 目录 摘要 .............................................................. I 1