A Model-Based Reference Architecture for Medical Device Development
Abstract
The application of systems engineering within the medical device domain must adapt to its unique challenges such-as the regulatory environment that these devices have to be designed within to ensure patient safety, and the nature of the interactions between the device and the patient. the sheer number of regulations imposed by government agencies such as the U.S. Food and Drug Administration and various international agencies adds to the complexity of designing these systems. This also presents an opportunity to implement a Model-Based Systems Engineering (MBSE) approach to capture the regulatory environment and map those specialized requirements to components within the system that address those requirements. in this study, we present a model of a reference architecture that can be used as a starting point for the system design of medical devices. Although the state of the model has not been fully matured, this approach offers the potential to more efficiently address the complex regulatory requirements, and reduce the time to design medical devices. © 2012 by Steven Corns and Battelle Memorial Institute.
Recommended Citation
S. Corns and C. Gibson, "A Model-Based Reference Architecture for Medical Device Development," 22nd Annual International Symposium of the International Council on Systems Engineering, INCOSE 2012 and the 8th Biennial European Systems Engineering Conference 2012, EuSEC 2012, vol. 4, pp. 2731 - 2740, International Council on Systems Engineering, Dec 2012.
Department(s)
Engineering Management and Systems Engineering
International Standard Book Number (ISBN)
978-162276916-2
Document Type
Article - Conference proceedings
Document Version
Citation
File Type
text
Language(s)
English
Rights
© 2024 International Council on Systems Engineering, All rights reserved.
Publication Date
01 Dec 2012
