Part 1. Essential Principles of Safety and Performance: Medical Devices
Frances Richmond(University of Southern California)
75 views
Part 2. Using Essential Principles of Safety and Performance in Medical Device Development
55 views
Classification of Medical Devices
Naoki Morooka(Japanese Medical Imaging and Radiological Industry Association (JIRA))
66 views
Medical Device Adverse Event Terminology
Ishikawa Hiroshi(University of Yamanashi)
49 views
Best Practice for Medical Devices Adverse Event Monitoring
Ki Chang Nam(Dongguk Univ. College of Medicine)
65 views
Adverse Event Investigation Process
Eric Woo(ECRI)
52 views
Adverse Event Reporting Process
Nur Hazreen Abdul Razak(Medical Device Authority (MDA), Ministry of Health Malaysia)
61 views
ISO 13485 Fundamentals: A Practical Approach to Medical Device Audits
Hyeonho Kim(Samsung Medison Co., Ltd.)
91 views
Risk Management and ISO 14971 with Focus on Practical Implementation
Jos van Vroonhoven(Philips)
Safety and Performance of In Vitro Diagnostic Medical Devices
You Kyoung Lee(Soonchunhyang University)
83 views
Classification of IVD Medical Devices
Hwan Sub Lim(Seoul Clinical Laboratories)
Clinical Evidence of IVD Medical Devices
Nurizzati Binti Haris Fadzilah(Medical Device Authority (MDA), Ministry of Health Malaysia)
Untact Conference 1: 2025, September 4th, 9 AM (KST) Opening and Introduction of SCH CoE and Speakers - Opening Remark: You Kyoung Lee, SCH APEC CoE How to Participate in the 2025 GHC-SCH APEC CoE Training - Presenter: Soe Ye Yint Tun, SCH APEC CoE
103 views
Untact Conference 2: 2025, October 17th, 9 AM (KST) Best Practices Series for Clinical Investigation - Emerging Issues and Techniques for Clinical Investigation - Presenter: Jaeson Choi, Ulsan University Q & A session for each lecture video - Moderator: C. Benson Kuo, University of Southern Calfornia Closing the 2025 Training
