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Medical Device (Soonchunhyang University)

AHC-SCH Medical Device CoE Pilot Training

Greg LeBlanc

  • Greg LeBlanc
    Director,
    Regulatory Affairs and Quality Systems,
    Cook Medical
    • Subject 1. Clinical Evaluation
      • Lecture 1: Clinical evaluation and evidence for medical devices

Hwan Sub Lim

  • Hwan Sub Lim
    Chief Medical Director,
    Laboratory medicine,
    Seoul Clinical Laboratories
    • Subject 1. Clinical Evaluation
      • Lecture 2: Clinical evaluation and evidence for IVD medical vices
    • Untact Conference 3: In Vitro Diagnostic Device in Laboratory Practice Experience for COVID‐19 realtime PCR

Yong Ho Lee

  • Yong Ho Lee
    Lead Auditor
    Medical Device Team
    SGS Korea
    • Subject 2: Quality Management System
      • Lecture 1: Overview of ISO13485/2016

Doug Reimer

  • Doug Reimer
    Senior Director,
    Regulatory Compliance,
    Johnson & Johnson
    • Subject 2: Quality Management System
      • Lecture 2: General Understanding of Medical Device Single Audit Program.
      • Best practice 2: Medical Device Manufacturer Perspectives ‐ MDSAP.

Eric Woo

  • Eric Woo
    Regional Director,
    Asia Pacific
    ECRI
    • Subject 2: Quality Management System
      • Lecture 3: MDV‐QMS intersection

Sun Young Jeong

  • Sun Young Jeong
    Head Manager,
    RA Department
    SD Biosensor
    • Subject 2: Quality Management System
      • Best practice 1: Medical Device Manufacturer Perspectives ‐ ISO 13485

Naoki Morooka

  • Naoki Morooka
    Vice-Division Manager,
    Regulatory and Safety Division,
    JIRA
    • Subject 3: Medical Device Vigilance
      • Lecture 1: Introduction to Medical Device Adverse Events

Ishikawa Hiroshi

  • Ishikawa Hiroshi
    Technical Advisor,
    Quality and Safety Department,
    PMDA
    • Subject 3: Medical Device Vigilance
      • Lecture 2: IMDRF Terms & Codes
      • Lecture 3: Exploration of IMDRF Adverse Event Terminology Web Browser

Frances Richmond

  • Frances Richmond
    Director and Professor,
    D K Kim International Center for Regulatory Science,
    University of Southern California
    • Untact Conference 1: Practical application of clinical evaluation in COVID‐19 Regulatory Approval (including EUA)

Hyeonho Kim

  • Hyeonho Kim
    Deputy Director,
    Medical Device Safety Bureau,
    MFDS
    • Untact Conference 1: Practical application of clinical evaluation in COVID‐19 Regulatory Approval (including EUA)

Danelle Miller

  • Danelle Miller
    VP, Global Regulatory Policy & Intelligence,
    Regulatory Policy & Intelligence,
    Roche
    • Untact Conference 2: Practical application of QMS in COVID-19 realtime PCR Manufacture

Jeff Boone

  • Jeff Boone
    Vice President,
    Quality Management,
    Roche
    • Untact Conference 2: Practical application of QMS in COVID-19 realtime PCR Manufacture

Hyuk Min Lee

  • Hyuk Min Lee
    Professor,
    Laboratory medicine,
    Yonsei University-Severance
    • Untact Conference 3: In Vitro Diagnostic Device in Laboratory Practice Experience for COVID‐19 realtime PCR