Risk Management For The Design And Development Process Of Immunity In Vitro Diagnostic Reagents

As a special kind of medical device products, in vitro diagnostic (IVD) reagents are directly related to the accuracy of medical diagnosis. Immune reagent market in China is at a rapid development stage. However the risk management activities for the in vitro diagnostic reagent design and development process are much less satisfactory compared with the same industry abroad. There is a big gap exists in the area. As a result, risk management methods and technical codes in the design and development process need to be set up for in vitro diagnostic reagent products.This thesis completed the following research:1) Defined the scope of the risk management in the design and development process of the in vitro diagnostic reagent, including design risk, process risk and other risks.2) Using a variety of tools for risk identification, safety feature list and risk identification process was optimized, established the damage list, check list and risk hierarchical classification criteria.3) Using failure mode and effect analysis for reaching the risk of design and development process, implementation method and sample table; Historical data method is adopted to establish the possibility standard and severity standard of the risk, and defined risk receiving matrix clearly.4) Three kinds of control are provided for design and process risk measures: performance control measures, the using control measures and process control measures, embodied in14kinds of control method, according to the implementation of priority into3levels.5) The result of this thesis has been applied in four products, a series of evaluation indexes are qualified. No abnormal external customer feedback is received. This quality control system can meet the requirements in the practical, reached the expected aim.In this thesis, we study the scope and details of the risk management in the design and development of the in vitro immune diagnostic reagents. Based on the theory of risk management, the thesis intended to conduct systematic analysis in vitro diagnostic reagents risk factors in the process of product design and development. Set up a series of tools, including risk checklist, risk assessment, standards, acceptance criteria, common risk control measures and effect evaluation. Actual operation confirmed that the results of this thesis can guide the enterprises to carry out the risk management in the design and development process of the in vitro diagnostic reagent. The obtained tools can be used as a template for similar product.