2020 AHC SCH Medical Device CoE Pilot Training
October 26 – Nobemver 17, 2020 | On-line training (Available for 3 weeks, total 9.3 hours)
| Method | Time | Topic | Speaker |
|---|---|---|---|
|
Subject 1. Clinical Evaluation (2.8hrs courses)
Objectives: 1) To understand the requirement of clinical evaluation for IVD based on IMDRF guidance 2) Discuss clinical trial design to secure IVD clinical evidence through virtual scenarios
Core curriculums: 1) Clinical Investigation (IMDRF MDCE WG/N57FINAL:2019) 2) Clinical Evaluation (IMDRF MDCE WG/N56FINAL:2019) 3) Clinical Evidence (IMDRF MDCE WG/N55 FINAL:2019)
Additional Documents: 1) GHTF/SG5/N6:2012 Clinical evidence for IVDs-Key Concepts 2) GHTF/SG5/N7:2012 Clinical evidence for IVDs-Scientific Validity 3) GHTF/SG5/N8:2012 Clinical evidence for IVDs-Clinical Performance Studies |
|||
|
VOD lectures |
40 mins |
Clinical Evaluation and Evidence for Medical Devices - Focused on IMDRF MDCE WG/N55, 56, 57 FINAL:2019 |
Greg LeBlanc (Cook Medical) |
| 40 mins |
Clinical Evaluation and Evidence for IVD Medical Devices - Focused on GHTF/SG5/N6,7,8:2012 |
Hwan Sub Lim (SCL) | |
|
Online activity |
30 mins |
Case study – Clinical Trial for COVID-19 real-time PCR |
|
|
Survey: 3~4 close-ended questions |
|||
|
Comment and Feedbacks |
|||
|
Untact Conference |
60 mins |
Live Video Conference 1 Practical Application of Clinical Evaluation in COVID-19 Regulatory Approval (including EUA) |
Moderator: Frances |
|
Subject 2. Quality Managament System (3.7hrs courses)
Objectives: 1) Introduce of ISO 13485 and MDSAP among QMS in VID 2) To share the best practices on ISO 13485 and MDSAP in IVD
Core curriculums: 1) ISO13485/2016 2) Medical Device Regulatory Audit Reports (MDSAP WG/N24:2015)
Additional Documents: 1) Quality management system –Medical Devices– Guidance on corrective action and preventive action and related QMS processes (SG3/N18: 2010) |
|||
|
VOD lectures |
40 mins |
Overview of ISO 13485:2016 |
Yong Ho Lee (SGS Korea) |
| 40 mins | General Understanding of Medecal Device Single Audit Program | Doug Reimer (J&J) | |
| 40 mins |
MDV-QMS Intersection - Quality managament system – Medical Device – Guidance on corrective action and preventive action and reated QMS processes (SG3/N18: 2010) |
Eric Woo (ECRI) | |
|
20 mins 20 mins |
Sharing Best practices - Medical Device Manufacturer Perspectives - ISO 13485 - MDSAP |
Sun Young Jeong (SD Biosensor) Doug Reimer (J&J) |
|
|
Untact Conference |
60 mins |
Live Video Conference 2 Practical Application of QMS in COVID-19 real-time PCR Manufacture |
Moderator: Danelle |
|
Subject 3. Medical Device Vigilance (2.8hrs courses)
Objectives: Building the ability to analyze the medical device adverse event occurring in the healthcare practice and express them using IMDRF terms & codes
Core curriculums: 1) Terminologies for Categorize Adverse Event Reporting: Terms, Terminology Structure and Codes (IMDRF/AE WG/N43 (Edition 4.1) FINAL:2020) & Update Annexes (Edition 4.1)
Additional Documents: 1) Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices (GHTF/SG2/N54R8:2006) |
|||
|
VOD lectures |
40 mins | Introduction to Medical Device Adverse Events |
Naoki Morooka (JIRA) |
| 30 mins | IMDRF Terms & Codes |
Ishikawa Hiroshi (PMDA) |
|
| 10 mins |
Exploration of IMDRF Adverse Event Terminology Web Browser |
Ishikawa Hiroshi (PMDA) | |
|
Online activity |
30 mins |
Case Study – BST |
|
|
Survey: 3~4 close-ended questions |
|||
|
Comment and Feedbacks |
|||
|
Untact Conference |
60 mins |
Live Video Conference 3 In Vitro Diagnostic Device in Laboratory Practice; Experience for COVID-19 real-time PCR |
Moderator: Hwan |
