Towards an Assurance Case Practice for Medical Devices
• Technical Note
Publisher
Software Engineering Institute
CMU/SEI Report Number
CMU/SEI-2009-TN-018DOI (Digital Object Identifier)
10.1184/R1/6585389.v1Topic or Tag
Abstract
Software technology enables an increasing percentage of medical device functionality, leading to much more complex systems and presenting a challenge to regulators charged with evaluating device safety and effectiveness. An approach to evaluating claims of safety increasingly used in Europe and elsewhere is the safety assurance case. Much like a legal case, the assurance case lays out an argument and supporting evidence to show that safety claims are valid.
This technical note explores the use of assurance cases for justifying claims of medical device safety. It illustrates the use of the assurance case on a particular type of medical device—the infusion pump. This example serves as a basis for discussing issues surrounding the introduction of assurance cases into the medical device community, which includes both manufacturers and the U.S. Food and Drug Administration.
Part of a Collection
Resources for Assurance Cases
Cite This Technical Note
Weinstock, C., & Goodenough, J. (2009, October 1). Towards an Assurance Case Practice for Medical Devices. (Technical Note CMU/SEI-2009-TN-018). Retrieved December 9, 2024, from https://doi.org/10.1184/R1/6585389.v1.
@techreport{weinstock_2009,
author={Weinstock, Charles and Goodenough, John},
title={Towards an Assurance Case Practice for Medical Devices},
month={{Oct},
year={{2009},
number={{CMU/SEI-2009-TN-018},
howpublished={Carnegie Mellon University, Software Engineering Institute's Digital Library},
url={https://doi.org/10.1184/R1/6585389.v1},
note={Accessed: 2024-Dec-9}
}
Weinstock, Charles, and John Goodenough. "Towards an Assurance Case Practice for Medical Devices." (CMU/SEI-2009-TN-018). Carnegie Mellon University, Software Engineering Institute's Digital Library. Software Engineering Institute, October 1, 2009. https://doi.org/10.1184/R1/6585389.v1.
C. Weinstock, and J. Goodenough, "Towards an Assurance Case Practice for Medical Devices," Carnegie Mellon University, Software Engineering Institute's Digital Library. Software Engineering Institute, Technical Note CMU/SEI-2009-TN-018, 1-Oct-2009 [Online]. Available: https://doi.org/10.1184/R1/6585389.v1. [Accessed: 9-Dec-2024].
Weinstock, Charles, and John Goodenough. "Towards an Assurance Case Practice for Medical Devices." (Technical Note CMU/SEI-2009-TN-018). Carnegie Mellon University, Software Engineering Institute's Digital Library, Software Engineering Institute, 1 Oct. 2009. https://doi.org/10.1184/R1/6585389.v1. Accessed 9 Dec. 2024.
Weinstock, Charles; & Goodenough, John. Towards an Assurance Case Practice for Medical Devices. CMU/SEI-2009-TN-018. Software Engineering Institute. 2009. https://doi.org/10.1184/R1/6585389.v1