Abstract
Fault or failure of software contained in medical devices will seriously endanger users and should be considered to reduce risk. In software development process, the risk analysis and risk control are very important for software contained in medical devices. In order to promote the quality of software contained in medical devices, a website is designed to provide the operating procedure of software contained in medical devices in this paper. The configuration management of software with operation procedure is managed by website based relational database developed by PHP and MySQL. Software process model, V-mode, is applied to guide software development process and used to promote the reliability of software. Moreover, fault tree analysis and failure mode and effects analysis are used to achieve risk analysis and risk control. The risk of software contained in medical devices can be effectively reduced. Therefore, software verification and validation is also integrated to verify and validate the function of software. Integrated Cephalometric Analysis System had been used to show that proposed approach is feasible.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Similar content being viewed by others
References
FDA (2002) General Principles of Software Validation
FDA (2005 /1998) Guidance for the Content of Pemarket Submission for Software Contained in Medical Devices
Ian Summerville (2006) Software Engineering, 8-th Edition, Addison-Wesley
James F. Peters (1999) Software Engineering: An Engineering Approach, Wiley
IEC TC/SC (2007) Fault tree analysis, IEC 61025 Ed. 1.0 b:1990
Stamatis D. H. (2003) Failure Mode and Effect Analysis: FMEA from Theory to Execution, American Society for Quality
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2008 Springer-Verlag Berlin Heidelberg
About this paper
Cite this paper
Chen, YJ., Liu, A.T., Chen, P.J., Chen, Y.T., Hsieh, U.Z., Cheng, K.S. (2008). Development of Website for the Operating Procedure of Software Contained in Medical Devices. In: Abu Osman, N.A., Ibrahim, F., Wan Abas, W.A.B., Abdul Rahman, H.S., Ting, HN. (eds) 4th Kuala Lumpur International Conference on Biomedical Engineering 2008. IFMBE Proceedings, vol 21. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-69139-6_17
Download citation
DOI: https://doi.org/10.1007/978-3-540-69139-6_17
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-69138-9
Online ISBN: 978-3-540-69139-6
eBook Packages: EngineeringEngineering (R0)