Introduction and Application Prospect of Risk Analysis Methods for Medical Devices
Meng Jiexiong Wang Yan Liu Zhicheng Capital Medical University School of Biomedical Engineering (Beijing 100069)
Based on risk analysis methods introduced by ISO 14971, this article summarizes the main methods currently used to analyze the risks associated with medical devices and their uses in international medical device industry. As well it presents the important global evolutions for the use and study of the risk analysis methods. The article discusses the different types, process mechanism, contributing factors and potential area of use(s) of those methods, and is designed to help the user select the appropriate method or combination of methods. On this basis, it makes the prospects about how to develop and enhance the research on methods of risk analysis for medical device for Chinese manufacturers and regulation authorities.