The Need for a Software Process Improvement Model for the Medical Device Industry

(*) Corresponding author

Authors' affiliations

DOI's assignment:
the author of the article can submit here a request for assignment of a DOI number to this resource!
Cost of the service: euros 10,00 (for a DOI)


Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the medical device industry. The paper details how medical device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration (CMMI®).
Copyright © 2017 Praise Worthy Prize - All rights reserved.


Medical device; Software Process Improvement Model; CMMI®

Full Text:



FDA Regulations. "Code of Federal, Regulations 21 CFR Part 820." June 1997.

FDA/CDRH Guidance Document. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." May 1998.

FDA/CDRH Guidance Document. "Guidance for Off-the-Shelf Software Use in Medical Devices." September 1999

FDA/CDRH Guidance Document. "General Principles of Software Validation." June 1997.

E.S. Crumpler, H. Rudolph, “FDA software policy and regulation of medical device software”, Food Drug Law Journal, Vol. 52, pp. 511-516, 1997.

R. R. Munsey, “Trends and events in FDA regulation of medical devices over the last fifty years”, Food Drug Law Journal, Vol. 50, pp. 163-177, 1995.

“Medical device reporting: Improvements needed in FDA’s system for monitoring problems with approved devices”, US General Accounting Office, GAO/HEHS-97-21, 1997

M.W. Bovee, D. L. Paul, K. M. Nelson, “A Framework for Assessing the Use of Third-Party Software Quality Assurance Standards to Meet FDA Medical Device Software Process Control Guidelines”, In: IEEE Transactions on Engineering Management, Vol. 48, No. 4, pp. 465-478, 2001.

To Err is Human: Building a Safer Health System, Linda Kohn, Janet Corrigan, Molla Donaldson, eds, National Academy Press 2000.

Failure Modes in Medical Device Software; An analysis of 15 Years of Recall data, Dollores R. Wallace and D. Richard Kuhn, NIST. Last accessed January 2007

Regulation of medical devices involving software in Australia – an overview, John Jamieson, 6th Australian Workshop on Safety Critical Systems and Software, Brisbane 2001.

Applying requirements management to medical devices utilizing software, Dean A. Leffingwell, Don R. Widrig and Wayne T. Morrissey, Rational Software Corporation 1997.

Developing safety-conscious software for medical devices, Timothy Cuff and Steven Nelson, Medical Device link archive January 2003.

ISPE, GAMP Guide for Validation of Automated Systems. GAMP 4, Dec 2001

ISO/IEC 15504: Information Technology – Process Assessment – Part 5: An exemplar Process Assessment Model, ISO/IEC JTC1/SC7, October 2003.

Capability Maturity Model® IntegrationCM (CMMISM) for Software Engineering (CMMI-SW, V1.1, Version 1.1, August 2002), CMMI Product Team, Technical Report CMU/SEI-2002-TR-028

Automotive SIG, The SPICE User Group Automotive Special Interest Group, Automotive SPICE Process Reference Model, 2005, available from

Cass, A. and Volcker C., SpiCE for SPACE: A method of Process Assessment for Space Projects, SPICE 2000 Conference Proceedings,

Medical device software-Software life cycle processes, ANSI(American National Standard)/AAMI (Association for the Advancement of Medical Instrumentation) SW68:2001.

J.Burton, F.McCaffery & I. Richardson, “A Risk Management Capability Model for use in Medical Device Companies”, 4th Workshop on Software Quality, ICSE 2006 Shanghai, China, 21st May 2006, pp 3-8.

F. Mc Caffery, D. McFall, P. Donnelly , F.G. Wilkie & R. Sterrit. “A Software Process Improvement Lifecycle Framework for the Medical Device Industry” , in Proceedings of the 12th Annual IEEE International Conference on the Engineering of Computer Based Systems (ECBS 2005),Greenbelt Marriott Hotel, Greenbelt, Maryland, USA (Washington DC metro), 3-8 April, 2005, Pages 273-280. ISBN 0-7695-2308-0

Mc Caffery F., O'Connor R. and Coleman, G., "Developing a Configuration Management Model for use in the medical device industry", in Filipe, Shishkov & Helfert (Ed's) Proceedings International Conference on Software and Data Technologies (ICSOFT), Portugal, 11th-14th September 2006, ISBN 9728865694, pp.81-88

ANSI/AAMI/ISO 14971, Medical devices – Application of risk management to medical devices. 2000

F. Mc Caffery , P. Donnelly, A. Dorling & F.G. Wilkie. (Apr 2004) "A Software Process Development, Assessment and Improvement Framework for the Medical Device Industry", Proceedings of Fourth International SPICE Conference on Process Assessment and Improvement, Lisbon, Portugal, 28-29 April 2004, SPICE User Group (Lisbon, Portugal), ISBN 972-9071-73-X, Pages 100-109.


  • There are currently no refbacks.

Please send any question about this web site to
Copyright © 2005-2023 Praise Worthy Prize