Current Result Document :
ÇѱÛÁ¦¸ñ(Korean Title) |
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¿µ¹®Á¦¸ñ(English Title) |
Credibility Assurance Methods for Evaluation of Medical Devices using Computational Modeling and Simulation |
ÀúÀÚ(Author) |
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Tae-hee Lee
Dong Hyun Go
Sukyoung Lee
Ji-won Lee
Ju-Yeon Lee
Ju-seon Lee
ChangWon Park
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¿ø¹®¼ö·Ïó(Citation) |
VOL 45 NO. 01 PP. 2452 ~ 2453 (2022. 06) |
Çѱ۳»¿ë (Korean Abstract) |
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¿µ¹®³»¿ë (English Abstract) |
Computational Modeling and Simulation (CM&S) is the next-generation regulatory paradigm for evaluating the safety and performance of medical devices. Recently, research to utilize computer modeling and simulation (CM&S) to evaluate medical devices has been actively conducted. In order to secure the reliability of the CM&S evaluation results, evaluation items were derived through the study of overseas regulatory trends related to CM&S. As a result of this study, the institutional basis was prepared by publishing a booklet on the format and content of the CM&S report. |
Å°¿öµå(Keyword) |
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