A new mathematical model-based approach in risk analysis of devices used in the medical device sector

In the medical device industry where quality and regulations are vital, Medical Device Regulation No. 2017/745 has been published in recent years following scandals that endanger product safety. The process of compliance with this regulation is a very important issue especially for Turkish producers and it contains very strict requirements. In this thesis, 2017/745 Medical Device Regulation has been compared with the 93/42/EEC Medical Device Directive which will be repealed in 2020 in order to facilitate the adaptation process and also FDA 21 CFR 820 regulation has been compared with the ISO 13485:2016 standard to provide an insight into the quality management systems of medical devices in USA and Europe. Risk management, which is a common focus of standards and regulation, is focused on and a new mathematical method for risk analysis is developed within the scope of the thesis. This developed method was applied to a medical device manufactured in a company and the results were obtained. The mathematical model was used to determine the risk factors of the device on the patients and users and to make the ranking of these risk factors important. With this model, it is aimed to minimize the risks that may occur for the patient and to determine the types of risks that should be taken into consideration. The risk management standard to be renewed is a recommendation for ISO 14971.