[Analysis of Common Questions in Medical Device Technical Review].

Risk management is an activity running through the full life of medical device, which has a significant effect on ensuring the safety and effectiveness of medical device. Many researchers do the research on medical device risk management from different perspectives, but few people discuss it from the technical perspective. The risk management issue in technical review of medical equipment was discussed, the reasons of the issue were analyzed, and suggestions were given in this study.

[Design Elements of Medical Endoscope and Concerns of Registration Technical Evaluation].

From the point of view of medical device registration technical evaluation, production process of endoscope, three-dimensional imaging(3D), high resolution imaging are discussed. We focus on the process of design and development, especially verification and validation. The general principle is that all risks and unexpected impacts should be minimized and acceptable to ensure that benefits are greater than risks in normal use.