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KMID : 1142220180130020125
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.125 ~ p.131
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Safety and Performance Evaluation Method of Implantable Medical Device Based on Advanced Technology
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Kim Dae-Chang
Kwon Ji-Yean
Jeong Jae-Hoon
Kim Sung-Min
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Abstract
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Although human life expectancy has increased with advances in medical technology, there are many problems with the increasing number of elderly people and the loss of human organ function. To address this problem, the development of implantable medical devices that can perform various functions inside the human body over a long period of time is actively carried out through advanced technologies combined. While fusion and combined technologies are focused on new performance, miniaturization, and remoteization, research on safety and performance evaluation methods of devices with new technologies is still insufficient. In this study, the recent technology trends applied to portable medical devices were investigated to derive the necessary common safety assessment methods and to present safety assessment methods considering the characteristics of the implanted devices. In addition, the performance evaluation criteria for implantable medical devices were established by comparing and analyzing the evaluation methods of non-implantable medical devices and implantable medical devices for similar purposes. As a result, we have presented a common assessment process for implantable medical devices, which is expected to be utilized for rapid acceptance of implantable medical devices with new technologies.
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KEYWORD
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implantable medical devices, safety, performance, miniaturization, remoteization
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