Exploration of quality management system of medical device clinical trials / 中华医学科研管理杂志

ABSTRACT

Objective:The standardized medical device clinical trials in China began in a short time, and the quality of trials needs to be improved.This article intends to explore possible ways for the improvement of quality management of the medical device clinical trials.Methods:Through working practice and literature review, analyze the current status of medical device clinical trials and in vitro diagnostic reagent in China; put forward targeted improved measures for the quality management system; as well as verify its feasibility through practice.Results:This article summarizes three factors that limit the improvement of the quality of medical device clinical trials, including the insufficient research and development strength of sponsors, the limited professional level of research teams, and the differences in verification and drugs, based on the risk-based quality management concepts, puts forward improved measures from three aspects, which including building risk-based quality certification system, making full use of electronic information systems to ensure the trial quality, and strengthening training of clinical trial capacity of researchers, and verifies the feasibility of these measures via the practical experience of our hospital since 2016.Conclusions:The application of risk-based quality management system, electronic information system and clinical trial capacity training can improve the management quality for medical device clinical trial centers.