关键词: font-size:medium, ">医疗器械；医工转化；检验检测

Abstract: The combination of medicine and engineering refers to the integration of medical knowledge and experience with engineering technology， so as to create new technologies and products to meet clinical needs. That is， medical concept and clinical needs，through a series of engineering and technological processes， finally become the technology， equipments， divices etc. to meet the clinical needs of patients. National top-level design attaches great importance to scientific and technological innovation， and the scientific and technological innovation of the medical device industry is developing rapidly. However， the combination of medicine and engineering is still restricted by many conditions， and the success rate of medical devices transformation is still quite low. In the process of turning medical idea into object/method，inspection and testing is always inseparable， and is the indispensable quality assurance method for products or methods. Clinical demanding projects need to develop research technical routes， which are realized by technical means. Technical means are finalized or quantified based on testing. Inspection and testing provide technical data for the feasibility of technical routes and the expected objectives of the research， and provide quality assurance for product research， production finalize until mass production， and complete the landing of clinical innovation projects. This paper expounds the current situation of combination of medicine and engineering and the current situation of the inspection and testing of medical devices， and analyzes the relationship between inspection and testing and the combination of medicine and engineering，so as to facilitate inspection and testing to better promote the transformation to medical devices.

Key words: font-size:medium, ">Medical devices； Combination of medicine and engineering； Inspection and testing