Program

Topic

Subject 1. Medical Devices

Offline Registration for in-person participants
Join the virtual meeting using [www.ebdiagnostics.org]
Intro & welcome messages
Essential principles of Safety and Performance of Medical Devices and IVD Medical Devices
Understanding the Clinical Evidence and Clinical Evaluation, an overview of IMDRF MDCE WG/N55 & N56 document
Best practice for clinical evaluation, systematic approach to synthesize clinical experiences
IMDRF principles and best practices for Clinical Investigation of medical devices
IMDRF terminologies for medical device adverse event Hands-on for IMDRF terminologies for medical device adverse event

Subject 2. IVD Medical Devices

Classification and conformity assessment of IVD medical devices Hands-on for classification of IVD medical devices
Offline Registration for in-person participants Join the virtual meeting using [www.ebdiagnostics.org]
Group discussion (Hands-on 1 and 2)
IMDRF terminologies for Medical device adverse event, Group presentation
Classification of IVD medical devices, Group presentation
Best practice for clinical evaluation, practical scientific approach for data generated through a literature review of IMDRF N56 (Only on SCH CoE website)


Time Topic Speaker
  • Subject 1. Medical Devices

    • Objectives:
    • 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
    Christine Gee
    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 Review of results for case study from 2021 virtual hands-on (10min) Group activity Kichang Nam / You Kyoung Lee
  • Subject 2. IVD Medical Devices

    • Objectives:

    • 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 Hosang Jung
    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
    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