Design Elements of Medical Endoscope and Concerns of Registration Technical Evaluation / 中国医疗器械杂志

ABSTRACT

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.