Exploration on the regulation mode of medical device quality and safety on a life-circle basis / 中国医疗器械杂志

ABSTRACT

A new conception of the life-circle state regulation for medical device's quality and safety is analyzed in the paper. The life-circle model and its corresponding regulation methods are discussed according to the characteristics of medical devices. Then, the regulation mode for application quality and safety of medical devices in a life-circle regulation system is explored.