Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
Frances Richmond(University of Southern California)
Understanding the Clinical Evidence and Clinical Evaluation, an overview of IMDRF MDCE WG/N55 & N56 document
Yazid S. Alazwari(Saudi Food & Drug Authority)
Best practice for clinical evaluation, systematic approach to synthesize clinical experiences
Eric Woo(ECRI)
IMDRF principles and best practices for Clinical Investigation of medical devices
Jaesoon Choi(University of Ulsan)
Best practice for clinical evaluation, practical scientific approach for data generated through a literature review of IMDRF N56
You Kyoung Lee(Soonchunhyang University )
IMDRF terminologies for medical device adverse event
Ishikawa Hiroshi(University of Yamanashi)
Classification of IVD medical devices
Jina Kim(National Institute of Food & Drug Safety Evaluation)