Title: Medical device design - an introduction to systems risk

Authors: Kaustav Jyoti Borah

Addresses: Electrical Engineering Department, California State University, Los Angeles, 5151 State University Drive, Los Angeles, California, 90032, USA

Abstract: Medical devices which are developed for human application can be used for diagnostic purposes. Researchers faced with some of the complex tasks that are making a medical device safe for human use. This means that the device should be safe, accurate and cost effective risk management that involves the identification, understand, control, and prevent failures that results in hazards exposures while humans use medical devices. Risk and hazard analysis, is a structured tool for evaluating the potential problems that could lead to encountered in connection with the use of taking a drug, or using a medical device. The purpose of this paper is to discuss the importance analysis of risk analysis, application of risk management tools, and the benefit of the risk management process. The final goal is to minimise use-related hazards, assure that intended users will be able to use the medical devices safely and effectively throughout the product life cycle, and to facilitate review of new device submissions and design control documentation.

Keywords: hazard analysis; ISO 14971; medical device design; systems risk; medical devices; risk management; risk assessment; medical safety.

DOI: 10.1504/IJISDC.2017.082870

International Journal of Intelligent Systems Design and Computing, 2017 Vol.1 No.1/2, pp.186 - 197

Received: 17 May 2016
Accepted: 27 May 2016

Published online: 10 Mar 2017 *

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