An Analysis of the Risk Management Process in a Medical Device Company

Abstract

With many medical device applications and the potential risks to patient safety, medical device manufacturers are challenged with the concern of product liability. This research focused on quality factors within the risk management process at Company XYZ that may contribute to product failures and recalls by regulatory bodies. History recall data was collected from U.S. FDA website on Company XYZ and analyzed for common trend. In addition, a check-sheet assessment based on ISO 14971 and the quality management system concepts was developed to compare the risk management process in the effort to mitigate device failures. Results indicated that Company XYZ device recall reached the highest numbers during the 2011 calendar year with a total of 95. Further observation revealed that recall categories totaled the highest in design and development. The results from the gap analysis check-sheet indicated the lack of proficiency in risk control efforts by employees. The lack of risk assessment tools such as preliminary hazard analysis inhibits a full extraction of the failure modes in early design and development stages. To improve the risk management system, upper management is recommended to create a risk-based culture to ensure adequate training and competency in risk assessments, methods and controls.