| Nowadays,with the rapid development of information technology,computers have become an indispensable necessity for people's work and life,the software is the core application of computers,it is an important tool for users to use and control.Therefore the quality of software will inevitably become the focus of it and everyone pays attention to it.Especially with the development of software technology,software systems are widely used in the medical field.Medical device software is included by a developed software system within a medical device being developed,or a software system that is intended to be developed as a medical device.The introduction of medical device software has brought great convenience and benefits to medical devices,and promoted the improvement of medical level.At the same time,the influence of software on the quality and safety of medical devices is also increasing.Hidden dangers and accidents alsooccur frequently.The quality management activities for the project and product quality requirements has become especially important in the development,manufacturing and production of medical devices.It is a very important method which is Guarantee the quality of the product by Implementing sound and effectivequalitymanagementInmedical device manufacturing companies.Strengthening project quality management can improve the quality of the product and reduce the maintenance costs and project operating costs.Project quality management is also a process of continuous improvement,it can also improve the efficiency of companies and enhance users' confidence in products in order to enhance the competitiveness in the market.Therefore,project quality management has received more and more attention from medical device manufacturing companies and even all other industries.This task selects the software quality management of the main computer console of the computed tomography scanner as the research subject in the Company where the author works.From its current status as an entry point,based on the theory of quality management,In-depth study of the software management process,Through the quality data in the software development process,which is sorted and analyzed,pointed out the problems and shortcomings of the project,Develop the improvement goals and conduct in-depth investigations and cause analysis of these issues,and finally the plan which if for the improvement plan is proposed for document management,demand management and test management,and the effectiveness of the improvement measures is evaluated,and finally effective safeguard measures are formed.This article includes the following main content:1.Firstly,the background,research significance,ideas,content and methods of this paper are introduced.2.Caring out important theories and tools for quality management;3.Analyzed the status and summary of the quality management of the CT main control station software project of the CT product R&D center of Neusoft Medical Systems Co.,Ltd.;4.Quality management improvement objectives and plans were formulated for specific problems,and detailed effect evaluations were carried out after the implementation of the plan;5.Implemented the measures for the quality management improvement of the CT main control station software project of the CT product R&D center of Neusoft Medical Systems Co.,Ltd.,so as to better consolidate the improvement results to ensure the long-term effectiveness of the measures;6.Finally,the paper summarizes and forecasts the full text.Successful attempt to improve the quality management of the CT main console software project of the CT Product Development Center of Neusoft Medical Systems Co.,Ltd.From the three aspects of document management,demand management and test management,we have explored an effective software quality management method for other domestic software companies.It is expected that an effective improvement reference scheme will be provided for the software quality improvement of other medical device companies in the industry. |
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