Study On Project Risk Management For Coating Urological Catheter Project

In modern medical institutions, disposable medical device is widely usedand plays a important role. Safety of medical device is closely related withpatient's health. Therefore, risk management is especially important fordisposable medical device, and ensures the success of product developmentproject. AS company is a manufacturer of disposable medical device. They weredeveloping coating urological catheter project. Risk management can helpimprove the product safety and guarantee companies to maximize benefits.First of all, the article introduces the present project risk management. Thenanalyze the AS company's coating urinary catheter project flow and importantpoint, and divide the whole project to five stage, product concept, plan, designand development, verification and validation and mass production. We study therule of risk management on every stage. Among them, first plan the riskmanagement, and identified all the risks from project important point. Riskchecklist for normal sterile catheter is raised in the process. Then all identifiedrisks are evaluated by FTA with Semi-quantitative method. At last, we find thesolutions for these root cause. The risk management will help self and othersimilar companies improve the project management, reduce the risk, to meet therequirement of end user.