Abstract

Risk management (RM) is an ongoing systematic approach which tends to predict future problems facing any product development process by analyzing loops of gathered or stored data and communicating their impact to enable design decision-making. It identifies problems, analyzes data, models and implements solutions and performs ongoing monitoring to assure that the corrective and/or preventive actions are being considered. As the majority of medical devices are monitoring devices, data communication and analysis play a crucial role in predicting the effectiveness and safety of a device. Device related data, patient related data and device-patient related data are great sources for enhancing either new designs or improving already existing ones. Analyzing such data can provide researchers and device development teams with a complete justification and patterns of interest about performance, life and safety. This paper introduces a review of the existing patents in the field of medical devices RM procedures, techniques and technologies as a mandatory requirement by the Food and Drug Administration (FDA) regarding the device approval and marketing. The paper focuses on the body of literature during three main stages of the device lifecycle; the design stage, the manufacturing stage and the device- user interface stage. The aim is to highlight major practices and their similarities as well as differences and future expectations for medical device risk assessment techniques. The authors use this study to guide the establishing of a new technique to quantify risk at the early design stage using device performance data under the umbrella of the RM procedure.

Keywords: Medical devices, regulatory system, risk assessment, risk management, validation and safety, verification.