Current Result Document :
| 한글제목(Korean Title) |
컴퓨터 모델링 및 시뮬레이션을 활용한 의료기기 평가의 신뢰성 확보방안 연구 |
| 영문제목(English Title) |
Credibility Assurance Methods for Evaluation of Medical Devices using Computational Modeling and Simulation |
| 저자(Author) |
이태희
고동현
이수경
이지원
이주연
이주선
박창원
Tae-hee Lee
Dong Hyun Go
Sukyoung Lee
Ji-won Lee
Ju-Yeon Lee
Ju-seon Lee
ChangWon Park
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| 원문수록처(Citation) |
VOL 45 NO. 01 PP. 2452 ~ 2453 (2022. 06) |
한글내용
(Korean Abstract) |
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영문내용
(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. |
| 키워드(Keyword) |
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| 파일첨부 |
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