Research On The Risk Management Of S Company Medical Devices

Medical device has been widely used in the prevention,diagnosis,treatment,health care and rehabilitation of the disease,which has become an important part of the field of clinical medicine.In recent years,the overall market size of China's medical devices continue to maintain rapid growth,is expected to become the world's third largest market after the United States and Japan.For China such a large population base,the upcoming"aging" society makes demand for medical devices is increasingly urgent,medical device products will be more widely spread.At the same time,the government released the"Opinions on Deepening the Reform of Medical and Health System" clearly identified:China will improve the primary health care service system,and gradually establish a system to meet the conditions of the classification,and effectively promote the level of basic medical and health services.The introduction of these policies has played a great role in promoting the development.Especially for imaging systems,who occupy the largest market segment in medical device industry.Analysis method such as literature research,interpretation of laws and regulations,field survey were applied for this thesis.After access to a large number of international standard and US,EU,Japan,China's regulation and industry standard,an overall picture of standard and regulation requirements from those key markets was generated.Emphasize that pay more attention on risk management is not only for business excellence,but also from compliance perspective.Based on the investigation of the company,this thesis describe the current risk management system,and the problems and shortcomings in the operation.Through the analysis of the risk management team,procurement process,manufacturing process,and post market process,it points out the root cause of the problems exposed in the life cycle of risk management.Learn from successful experiences of the medical device industry,3 companies' best practices are introduced,including special controls in the team management,facility management and manufacturing management.So as to provide the reference in the risk management of strategical thinking and positioning.According to current status update and lesson learn,to continuous improve the company's core competence in healthcare imaging system market,company need to consider capability,think from the implementation strategy of organization design,establish the risk management culture,re-structure the organization risk management system and setup the strategical control system on risk management.To improve the overall direction and structure of risk management,so as to continuously enhance the enterprise s competitiveness in medical imaging in the future market.