Paper Title
Risk Aspects and Medical Device Development Process

Abstract
Medical devices aim to monitor, replace or modify physiological processes and thus contribute to the maintenance and/or improvement of quality of life. However, the development of a new medical device is often uncertain and quite expensive. Therefore, designers and developers of a new medical device try to detect the risks, which each phase of medical device development process may encounter.The purpose of this article is to detect and discuss the risks and their sources, as well as their mitigation during the MDD process. This was done by a literature review of available sources found on the research topic in Web of Science and Scopus.The findings show the main risks during the MDD process together with their sources and their management. They reveal that the detection of risks and their sources in the MDD process plays a significant role since it can prevent a lot of adverse effects on the use of medical devices by the end users, save a lot of time on medical device design and development, as well as to reduce costs during the whole MDD process. Index Terms - Identification, medical device development, risks, sources.