DEVELOPING A CONFIGURATION MANAGEMENT MODEL FOR USE IN THE MEDICAL DEVICE INDUSTRY
Fergal McCaffery, Rory O’Connor, Gerry Coleman
2006
Abstract
This paper outlines the development of a Configuration Management model for the MEDical device software industry (CMMED). The paper details how medical device regulations associated with Configuration Management (CM) may be satisfied by adopting less than half of the practices from the CM process area of the Capability Maturity Model Integration (CMMI). It also investigates how the CMMI CM process area may be extended with additional practices that are outside the remit of the CMMI, but are required in order to satisfy medical device regulatory guidelines.
References
- Automotive SIG, The SPICE User Group Automotive Special Interest Group, Automotive SPICE Process Reference Model, 2005.
- Baskerville R. and Pries-Heje J., Knowledge Capability and Maturity in Software Management, in The Data Base for Advances in Information Systems, Spring 1999, Vol. 30, No. 2, 26-43.
- Cass, A. and Volcker C., SpiCE for SPACE: A method of Process Assessment for Space Projects, SPICE 2000 Conference Proceedings, http://www.synspace.com
- Chrissis, M.B., Konrad, M. & Shrum, S., CMMI: Guidelines for Process Integration and Product Improvement, Addison Wesley, 2003
- Cusumano M. and Yoffie D., Software Development on Internet Time, IEEE Computer, Vol. 32, No. 10, Oct. 1999, 60-69.
- European Council Directive 93/42/EEC Concerning Medical Devices, 14 June 1993.
- Fayad M. and Laitinen M., Process Assessment Considered Wasteful, Communications of the ACM, Vol. 40, No. 11, 1997, 125-128.
- FDA Regulations, Code of Federal Regulations 21 CFR Part 820, Food and Drug Administration, June 1997.
- FDA/CDRH Guidance Document, General Principles of Software Validation, FDA, June 1997.
- FDA/CDRH Guidance Document, Guidance for Off-theShelf Software Use in Medical Devices, FDA, September 1999
- FDA/CDRH Guidance Document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, FDA, May 2005.
- GAMP, Guide for Validation of Automated Systems (GAMP 4), International Society for Pharmaceutical Engineering, December 2001
- Ghezzi C., Jazayeri M. and Mandrioli D., Fundamentals of Software Engineering, Prentice Hall, 2003.
- Humphrey W., Introduction to the Team Software Process, Addison Wesley, 2000.
- ISO/IEC 15504, Information Technology - Process Assessment - Part 5: An exemplar Process Assessment Model, ISO/IEC JTC1/SC7, October 2003.
- ISO/IEC 12207, Information technology - Software lifecycle processes Amendment 2, International Standards Organisation, 1995.
- Jonassen-Hass M.E., Configuration Management Principles and Practice, Addison Wesley, 2002.
- Medical device software life cycle processes, American National Standard / Association for the Advancement of Medical Instrumentation, SW68, 2001.
- McCaffery F., Donnelly P., Dorling A. and Wilkie G., A Software Process Development, Assessment and Improvement Framework for the Medical Device Industry, Proceedings Fourth International SPICE Conference on Process Assessment and Improvement, Lisbon, Portugal, April 2004.
Paper Citation
in Harvard Style
McCaffery F., O’Connor R. and Coleman G. (2006). DEVELOPING A CONFIGURATION MANAGEMENT MODEL FOR USE IN THE MEDICAL DEVICE INDUSTRY . In Proceedings of the First International Conference on Software and Data Technologies - Volume 1: ICSOFT, ISBN 978-972-8865-69-6, pages 81-88. DOI: 10.5220/0001311900810088
in Bibtex Style
@conference{icsoft06,
author={Fergal McCaffery and Rory O’Connor and Gerry Coleman},
title={DEVELOPING A CONFIGURATION MANAGEMENT MODEL FOR USE IN THE MEDICAL DEVICE INDUSTRY},
booktitle={Proceedings of the First International Conference on Software and Data Technologies - Volume 1: ICSOFT,},
year={2006},
pages={81-88},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0001311900810088},
isbn={978-972-8865-69-6},
}
in EndNote Style
TY - CONF
JO - Proceedings of the First International Conference on Software and Data Technologies - Volume 1: ICSOFT,
TI - DEVELOPING A CONFIGURATION MANAGEMENT MODEL FOR USE IN THE MEDICAL DEVICE INDUSTRY
SN - 978-972-8865-69-6
AU - McCaffery F.
AU - O’Connor R.
AU - Coleman G.
PY - 2006
SP - 81
EP - 88
DO - 10.5220/0001311900810088