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A new hybrid method to determine the hazardous risk factors

Abstract In risk analysis, the quantification of risk, the modeling of identified risk, and how to make decisions are all topics considered. Risk analysis activity that companies must comply with and perform at a minimum level to produce medical devices. Manufacturers should consider all risks that the device may contain to indicate that the medical device is safe. Manufacturers must also justify that this device should be manufactured because the benefit of the device is greater than the risk. This study proposes a method to measure the risk factors of the medical devices on the patient. Accordingly, a mathematical model is developed, the model is applied to a device manufactured in a company, and the results are obtained. The aggregated method developed in this study, based on the Taguchi loss function and using the hesitant fuzzy the technique for order preference by similarity to ideal solution (HF-TOPSIS) method, ensures that the risks that may occur for the patient are minimized and the risk types to be taken into account are determined. In addition, the order of importance of the risk types obtained with the proposed method in the study is compared with the TOPSIS method.