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9.3.2 Assurance Cases: A New Form of Requirements Traceability Matrix for Medical Devices
Author(s) -
Eubanks Fritz,
Masters Melissa
Publication year - 2011
Publication title -
incose international symposium
Language(s) - English
Resource type - Journals
ISSN - 2334-5837
DOI - 10.1002/j.2334-5837.2011.tb01271.x
Subject(s) - traceability , medical device , risk analysis (engineering) , computer science , quality assurance , engineering management , process management , engineering , software engineering , medicine , operations management , biomedical engineering , external quality assessment
Scientific and medical innovations have led to great improvements and advancements in the lives of people around the world. As technology has progressed so has the complexity of the medical devices that have been created. Not only has the technical complexity increased but additionally, the user interaction with the device has also become more complex and involved. Both of these intricacies have been identified as complicating factors in the safe and effective use of infusion pumps. To this end, the FDA identified an initiative in April of 2010 to address these concerns. One outcome that was identified is the requirement to perform an assurance case. This requirement presents several challenges to practicing medical systems engineers to ensure the assurance case report is complete and assures the device is arguably wholly safe and effective.