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)
    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    		 Christine Gee
    45 mins Best practice for clinical evaluation,
    systematic approach to synthesize clinical experiences     		Eric Woo
    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
    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
    - Review of results for case study from 2021 virtual hands-on (10 mins)
    - Group activity     		Kichang Nam /
    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 Ho-Sang Jeong
    55 mins Hands-on for classification of IVD medical devices
    - How to use the navigator for IVD classification (10min)
    - Group activity    		 Soe Ye` Yint Tun /
    You Kyoung Lee
    60 mins Group discussion for Hands-on 1
    - IMDRF terminologies for Medical device adverse event, Group presentation     		Moderator Ishikawa Hiroshi
    60 mins Group discussion for Hands-on 2
    - Classification of IVD medical devices, Group presentation     		Moderator Hwansub Lim