Discussion of Medical Device Test Report Review and Quality Control Management
Objective:Medical devices have the characteristics of complexity,particularity,professionalism,and wide range of involvement,faced with the growing competitive situation in the open self-test and inspection market of medical devices,it is a common challenge faced by all medical device inspection institutions,that to enhance inspection capabilities,adapt to the rapid development of the Medical devices industry,and ensure the scientificity,fairness,and authority of inspection results.Methods:In this article,the challenges faced by medical device inspection,legal and regulatory requirements,and the key points of quality management system were described.Results:Quality improvement measures and suggestions were proposed based on the issues identified during the test report review.Conclusion:Medical device inspection institutions should continuously improve their inspection capabilities,develop special advantages,actively respond to the needs of the rapid development of medical devices and the new situation of testing,improve quality and efficiency,should be in the quality inspection work of medical devices,the introduction of risk management concepts and strengthen process control,from the human,machine,material,law,environment and other aspects of the construction of a comprehensive security system to improve inspection quality and efficiency and assist in the high-quality development of medical devices.
medical devicestest reportquality controlregistration self-testingrisk control
万方数据
维普
