Risk Analysis Application for a Medical Device Manufacturer

Abstract

The concept of risk assessment became important with economic and technological developments in the 1920s. After World War II, damage became more important with the fact that potential accidents and all risks resulting in damage and injury could be controlled and managed. With this importance, organizations in developed countries have focused on risk assessment activities in their respective fields. Risk assessment is one of the most important and critical steps of risk management. While the concept of risk assessment is new in our lives, its content and methods are not new. Risk assessment and analysis methods have been applied around the world since the 1930s. The lack of practice in the companies that produce medical devices related to risk assessment reveals the importance of working on this issue. This study was conducted using Risk Assessment Method in a medium-sized factory operating in the medical device sector in Istanbul. This assessment was carried out in conjunction with the company’s quality team. The results of the evaluation were examined and the risk outcomes were determined by taking into consideration the events, the returns of the patients and the possible risks.