On the Medical Device Approval System for Risk Management

Abstract

Since most medical devices have a lot of hazardous risks, a risk management standard for medical equipments shall be appropriately controlled and maintained for human safety. For effective operation of regulations, procedures and risk management standards for the safety of medical devices, the safety of the medical device operating system products, compliance with the regulation, infrastructure and environment as well as operating system management of human resources are of extreme importance. In order to provide implemented suggestions to this end, we applied a qualitative method of the FMEA as an objective analysis for given business environments. As a result, it is realized that the specific properties in the risk management process shall be resolved in the objective point of view, and a proper quality management system in terms of hazards shall be provided. In this study, through reconsidering the issues in the medical device approval system such as procedures and standards applied in the risk management system, important risk factors are suggested to identify to be proper operating system.