Education


2022 SCH APEC Medical Device CoE Training

November 7th & 8th, 2022 l Online and Offline (COEX, Seoul) Training

Time Topic Speaker

  • Subject 1: Medical Devices

    Objective:
    1) To understand the requirement of clinical evaluation for medical devices based on IMDRF guidance
    2) To share the best practices in clinical investigation for medical devices

    Core Curriculums:
    1) Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N047: 2018)
    2) Clinical Investigation (IMDRF MDCE WG/N57FINAL:2019)
    3) Clinical Evaluation (IMDRF MDCE WG/N56FINAL:2019)
    4) Clinical Evidence (IMDRF MDCE WG/N55 FINAL:2019)
    5) IMDRF terminologies for categorized Adverse Event (IMDRF AE WG/N43 FINAL:2020)
    30 mins Offline Registration for in-person participants
    Join the virtual meeting using [www.ebdiagnostics.org]     		SCH CoE
    30 mins Intro & welcome messages SCH CoE
    45 mins Essential principles of Safety and Performance of Medical
    Devices and IVD Medical Devices     		Frances Richmond
    and
    Ishikawa Hiroshi
    45 mins Understanding the Clinical Evidence and Clinical Evaluation,
    an overview of IMDRF MDCE WG/N55 & N56 document     		TGA (TBD)
    45 mins Best practice for clinical evaluation, systematic approach to
    synthesize clinical experiences     		Eric Woo
    45 mins IMDRF principles and best practices for Clinical Investigation of
    medical devices     		Jaesoon Choi
    45 mins IMDRF terminologies for medical device adverse event Ishikawa Hiroshi
    60 mins Hands-on for IMDRF terminologies for medical device adverse event You Kyoung Lee

  • Subject 2: IVD Medical Devices

    Objective:
    1) To understand harmonized approach to the classification of IVD medical devices
    2) To understand the harmonized approach to conformity assessment focusing on the IVD medical devices

    Core Curriculums:
    1) Principles of IVD Medical Devices Classification (SG1/N045: 2008)
    2) Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices (SG1/N046: 2008)
    45 mins Classification and conformity assessment of IVD medical devices MFDS
    55 mins Hands-on for classification of IVD medical devices Soe Ye` Yint Tun/ You Kyoung Lee
    20 mins Offline Registration for in-person participants
    Join the virtual meeting using [www.ebdiagnostics.org]     		SCH CoE
    120 mins Group discussion (Hands-on 1 and 2) Moderator for Hands-on 1, Ishikawa Hiroshi
    Moderator for Hands-on 2, Hwansub Lim
    60 mins IMDRF terminologies for Medical device adverse event, Group presentation representatives of each group
    60 mins Classification of IVD medical devices, Group presentation representatives of each group
    60 mins Best practice for clinical evaluation, practical scientific
    approach for data generated through a literature review of
    IMDRF N56 (Only on SCH CoE website)     		You Kyoung Lee