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A Model‐based Reference Architecture for Medical Device Development
Author(s) -
Corns Steven,
Gibson Chad
Publication year - 2012
Publication title -
incose international symposium
Language(s) - English
Resource type - Journals
ISSN - 2334-5837
DOI - 10.1002/j.2334-5837.2012.tb01457.x
Subject(s) - computer science , architecture , domain (mathematical analysis) , systems engineering , food and drug administration , risk analysis (engineering) , medical device , reference architecture , architecture framework , systems architecture , government (linguistics) , software engineering , process management , engineering , software architecture , business , art , mathematical analysis , biomedical engineering , mathematics , software , visual arts , programming language , linguistics , philosophy
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.