As is known to all, medical raw materials ago since in industrial materials, happen to coincide with biocompatible, radioactive, microbial pollution, chemical residues and degradation of practical problems. Due to the above reasons, from the production process to the clinical application of different stages, because of its span, applied to the human body to be affected by the internal and external environment and other complex factors. Therefore, the material for the adaptability of the human body with uncertainty, and chemical materials on human safety evaluation, often requires long-term, a large number of experimental studies to verify its effectiveness.
In order to increase the correct rate of the research results, the choice of the medical device clinical trial should ensure the homogeneity. In the course of the experiment, we should also consider the safety of the subjects and know how to control the cost. Under this condition, the subjects tend to be concentrated in a relatively narrow range. However, after the medical device is listed, it is widely used in different individuals, some defects, only new products after a long time, a large number of clinical use can be found. Therefore, in contrast with the actual situation of the use of the listing, the test process and found that the defects of new products are limited. Bring 4.4 new medical devices in the application process challenge.Due to the particularity of medical equipment, from its design, production, into clinical trials, into the market, there is a certain risk.