Notes

Risk Actions inside Youngsters Together with and also Without Tourette Malady.
To investigate the pre-treatment preventive maintenance and quality control procedure of MRI system and transcranial MRI-guided focused ultrasound (TcMRgFUS) treatment system by monitoring quality control of these two systems.

The general performance index and image quality control index of MRI system, as well as the quality assurance program of TcMRgFUS EXABLATE 4000 system were tested and recorded.

The general performance index and image quality control index of MRI system met requirements.

Through system detection, the system performance could be monitored, ensuring the accuracy and safety of surgery.
Through system detection, the system performance could be monitored, ensuring the accuracy and safety of surgery.
To investigate the risk of adverse events in the clinical use of infant incubators of three kinds of national medical devices in Zhejiang Province.

Semi-quantitative matrix analysis was used to analyze the risk of adverse events related to incubator products in Zhejiang province from August 2018 to August 2019.

Through the risk analysis of 213 cases of adverse events of infant incubator product, the risk point and degree of the product in practical clinical application were evaluated.

Through the evaluation results of the production enterprises, medical institutions put forward relevant recommendations to reduce the risk of product use to prevent the recurrence of serious adverse events in the use of the product and spread.
Through the evaluation results of the production enterprises, medical institutions put forward relevant recommendations to reduce the risk of product use to prevent the recurrence of serious adverse events in the use of the product and spread.The cut off value or reference interval is significant in clinical testing and diagnosis. If there is no scientific and reasonable cut off value or reference interval for in vitro diagnostic reagents, clinicians can not make medical decisions on patients through the results. The test will be meaningless, so the cut off value or reference interval study is an important part of the preclinical study of in vitro diagnostic reagents. In this article, combined to the review experience of related product, we discuss the establishment and verification of the cut off value and reference interval to provide a reference for relevant manufacturers.Reference interval study and clinical evaluation are crucial supportive researches to demonstrate the intended use of quantitative in vitro diagnostic reagents. The process of determining reference interval, as well as the problems found frequently in clinical evaluation, are discussed here, and the links between them are analyzed from the aspects of product's traceability, intended use and group design. Further, some suggestions are offered in this paper.Since the outbreak of COVID-19, the accurate and rapid clinical diagnosis technology of SARS-CoV-2 has played a crucial role in the prevention and control of epidemic situation. This study aims to analyze and discuss the key points for quality control of 2019 novel coronavirus testing kits, while incorporating the actual testing process, the distribution of testing kits and interpretation of relevant policies and regulations.
Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.

Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.

The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.

During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
Thinking on the construction of the medical device type archives information system.

This paper introduces the concept and significance of medical device variety archives, and puts forward the overall construction idea and system framework of medical device variety archives by analyzing its construction difficulties.

Considering the long-term nature and complexity of the construction of medical device variety archives, the system can be constructed in accordance with the three steps of system building, platform building and data management, and the overall technical architecture can be designed from the eight aspects of user layer, business application layer, application support layer, data resource layer, infrastructure layer, security, standards and operation and maintenance management.

Architecture design is the foundation of system construction, and its design rationality is very important for the success of system construction. The architecture design proposed in this study has a certain reference role for promoting the construction of medical device variety archives management system.
Architecture design is the foundation of system construction, and its design rationality is very important for the success of system construction. FPS-ZM1 cost The architecture design proposed in this study has a certain reference role for promoting the construction of medical device variety archives management system.This article expounds relevant policies of domestic medical device "MAH Policy" in recent years. When facing new development opportunities at this time of policy innovation, "Speed Dial Management" model summarized through the practice of "MAH Policy", together with the core elements of "three parties, three regulations and three flows" extracted from it, form a standardized, implementable and reproducible management mechanism. The experience has strong reference significance for the promotion and implementation of "MAH Policy" among medical device industry.
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