Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
Frances Richmond(University of Southern California)
Best Practice for clinical evaluation, systematic approach to synthesize clinical experiences
Eric Woo(ECRI)
Best Practice for clinical evaluation, practical scientific appraoch for data generated through a literature review of IMDRF N56
You Kyoung Lee(Soonchunhyang University)
IMDRF principles and best practices for Clinical Investigation of medical devices
Jaesoon Choi(Asan Medical Center, University of Ulsan College of Medicine)
IMDRF terminologies for medical device adverse event
Ishikawa Hiroshi (University of Yamanashi)
Review of results for case study from 2021 virtual hands-on
Ki Chang Nam(Dongguk University College of Medicine)
Classification and conformity assessment of IVD Medical Devices
Ho-Sang Jeong(NIFDS)
IVD Medical Device Classification Tool
Soe Ye Yint Tun
