Biomaterial Database

Risk-based validation of multilingual medical devices. 2007

Alan Kusinitz, and Kai Simonsen

SoftwareCPR, USA.

UI	MeSH Term	Description	Entries
D004864	Equipment and Supplies	Expendable and nonexpendable equipment, supplies, apparatus, and instruments that are used in diagnostic, surgical, therapeutic, scientific, and experimental procedures.	Apparatus and Instruments,Devices,Medical Devices,Device, Medical,Devices, Medical,Equipment,Inventories,Medical Device,Supplies,Device,Instruments and Apparatus,Inventory,Supplies and Equipment
D012307	Risk Factors	An aspect of personal behavior or lifestyle, environmental exposure, inborn or inherited characteristic, which, based on epidemiological evidence, is known to be associated with a health-related condition considered important to prevent.	Health Correlates,Risk Factor Scores,Risk Scores,Social Risk Factors,Population at Risk,Populations at Risk,Correlates, Health,Factor, Risk,Factor, Social Risk,Factors, Social Risk,Risk Factor,Risk Factor Score,Risk Factor, Social,Risk Factors, Social,Risk Score,Score, Risk,Score, Risk Factor,Social Risk Factor
D012984	Software	Sequential operating programs and data which instruct the functioning of a digital computer.	Computer Programs,Computer Software,Open Source Software,Software Engineering,Software Tools,Computer Applications Software,Computer Programs and Programming,Computer Software Applications,Application, Computer Software,Applications Software, Computer,Applications Softwares, Computer,Applications, Computer Software,Computer Applications Softwares,Computer Program,Computer Software Application,Engineering, Software,Open Source Softwares,Program, Computer,Programs, Computer,Software Application, Computer,Software Applications, Computer,Software Tool,Software, Computer,Software, Computer Applications,Software, Open Source,Softwares, Computer Applications,Softwares, Open Source,Source Software, Open,Source Softwares, Open,Tool, Software,Tools, Software
D012986	Software Validation	The act of testing the software for compliance with a standard.	Software Verification,Software Validations,Software Verifications,Validation, Software,Validations, Software,Verification, Software,Verifications, Software
D018570	Risk Assessment	The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)	Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments
D018795	Device Approval	Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.	Device Approval Process,New Device Approval,Food and Drug Administration Device Approval,Food and Drug Administration Device Approval Process,New Device Approval Process,Approval Process, Device,Approval Processes, Device,Approval, Device,Approval, New Device,Approvals, Device,Approvals, New Device,Device Approval Processes,Device Approval, New,Device Approvals,Device Approvals, New,New Device Approvals,Process, Device Approval,Processes, Device Approval
D019303	Multilingualism	The ability to speak, read, or write several languages or many languages with some facility. Bilingualism is the most common form. (From Random House Unabridged Dictionary, 2d ed)	Bilingualism
D038622	Internationality	The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)	Globalization,International Aspects,International Perspectives,International Relations,Multinational Aspects,Multinational Perspectives,Aspect, International,Aspect, Multinational,Aspects, International,Aspects, Multinational,International Aspect,International Perspective,Multinational Aspect,Multinational Perspective,Perspective, International,Perspective, Multinational,Perspectives, International,Perspectives, Multinational,Relations, International

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