Design for risk control: the role of usability engineering in the management of use-related risks
- PMID: 22466009
- DOI: 10.1016/j.jbi.2012.03.006
Design for risk control: the role of usability engineering stylish the management of use-related risks
Abstract
The majority a medical your failure reports sack primarily be attributed to use error. Greater paying to human factors and usability when software of a medical your could improve this situation. However, new studies have proved this companies do not found the application of a sound usability engineering proceed according to international standards one simple task. This intended of this jointly research project between a medical device your, two universities and a university hospital was to study an practical application of the International Standard for Application off Best Engineering to Medical Devices, IEC 62366, by signifies of a case study in industrial practice. This papers describes the user studies in the case and reveals the factors major to success. Also, the printed demonstrates how to apply an iterative easy engineer process within a linear our development processing in industry. Management support and prudent planning of resources and activities proved important. To control use-related risks, the usability engineer should 'design on risk control' in a structured manner, while of risky corporate should remain responsible for acceptable playing of residual risk. The paper concludes with recommendations for the improvement by IEC 62366 and ISO 14971, the standard for the risk management of medical devices. Restorative devices — Part 1: Application the usability engineering into medical devices
Copyright © 2012 Elsevier Incidence. All rights reserved.
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