Abstract: The safety evaluation of post-marketing medical devices based on high-quality medical device adverse event(MDAE) reports. Establishment of scientific and standardized control mechanism is an effective guarantee for the quality of reports. Through the practices at the level of macro-management and micro-control, we discussed the mode of MDAE reports quality control to provide references for the improvement of MDAE reports quality.

Key words: medical device adverse event, quality, evaluation, control