A Study Of Risk Management At The In Vitro Diagnostic Reagents Medical Device Projects

Modern diagnostic and treatment are highly dependent on medical devices in modern medical institutions, IVD is vested in the management of medical devices, the main purpose is to carry out a priori services for the medical treatment, it is also a basic tool that can detect whether a patient is sick or even the severity of disease.IVD industry has broad market prospects as an emerging field, but the great profits often accompanied with huge risks, Accuracy of the results directly affects the doctor’s diagnosis, health of the patients and the safety of their lives. Therefore, it is particularly important to make effective device on risk management.This thesis establishes a set of effective managements, which is suitable for the diagnosis of similar risks. It is according to the IVD manufactures that have primarily responsible for the risks of medical devices. The main contents of research are as follows:First, developing process and characteristic in according with the in vitro diagnostic reagents project. By using the method of work breakdown flow chart and combined with life cycle in different stages to preliminary identify all the risks, we can give a summary of8categories risk characteristics including technology risk, management risk etc.Second, according to the survey results of indicators rational expert and qualitative analysis on the risks, to determine the distribution and probability of risk factors, and the severity of their impact on the project after the occurrence, we give a conclusion of14risk resources including product competitiveness, overall quality, etc. It provides basis for selecting a reasonably risk countermeasure.Third, starting from the five stages of in vitro diagnostic medical devices projects; we established a model of a hierarchical structure for the similar projects. Evaluating various risk factors by using the Analytic Hierarchy Process (AHP) method, confirming the importance of all kinds of risk factors, we summarize the main risk factors in vitro diagnostic projects should be focus on.Compared results of qualitative analysis with quantitative analysis, it demonstrate that the index system proposed in this thesis is reasonable and scientific, the evaluation method is practical and is used properly. Combined with the cases on the theory method, proved the risk management process of in vitro diagnostic medical device the project is effective. This thesis constructed a risk evaluation index system of IVD reagents medical device projects, established a sustainable and dynamic risk analysis model, provided some suggestions to similar project risk management, These research are benefit to make a correct standard for R&D process of new products; benefit to analyze and forecast the potential risks and to make controlling measures to reduce the risk, the purpose of risk management is to ensure the quality of new products, and to make more profits for the enterprise ultimately. This thesis has theoretical significance and application value, so as to provide useful reference for the risk management of IVD reagents medical device projects.