The Medical Device Risk Management Study Of Manufacturers Perspective

Medical Devices as a special product, its safety and effectiveness with people’s healthand life are closely related to people’s health and life. The risk of medical devices also includesocial and environmental property damage. As a manufacturer of medical devices, both fromthe patient, user and other persons responsible for the point of view or from the perspective ofmeeting regulatory requirements, comprehensive and effective implementation of the medicaldevice risk management activities, all necessary work.Based on the manufacturer perspective on how manufacturers rely on internal press YY/T0287-2003standard for establishing, implementing the quality management system,implement YY/T0316-2008standards, requirements for risk management in the organicintegration of quality management system among establish a complete product lifecyclecovering the whole process of risk management system. Firstly, the current research werereviewed; against YY/T0316-2008standard terms of the resolution, to clarify the proceduresand methods of risk management activities, and several common risk analysis tools werecompared to determine their scope; from the manufacturer’s perspective on how differentcategories of medical devices to carry out a risk analysis, risk assessment and risk controlactivities were analyzed, trying to find its inherent laws, investigate risk analysis toolworkable on risk analysis evaluation and risk control process of the key points and issues thatneed attention are discussed and summarized. Finally, the effectiveness through the"polylactic acid anti-adhesion film," An Empirical Study of risk management products, riskanalysis studies to verify the operability of tools and risk control measures. This study willhelp to build or improve the medical device manufacturer ’s risk management system.