Introduction to System Risk in Medical Device Design

Abstract

Medical devices designed for human use can be used to help patients overcome illness or disease and improve their quality of life. Researchers are working with more difficult tasks involved in making a medical device fit for human use. This means that the device should be safe, accurate, and cost-effective in terms of risk management, which entails identifying, understanding, controlling, and preventing failures that result in hazardous exposures while humans use medical devices. Risk and hazard analysis is a structured approach for assessing the potential difficulties that could arise from the usage of a medicine or a medical device. The purpose of this paper is to examine the necessity of risk analysis, risk management tools, and the risk management process's benefits. The ultimate goal is to reduce use-related risks, ensure that intended users can safely and effectively utilize medical devices throughout the product life cycle, and simplify the assessment of new device submissions and design control documents.