skip to content

Medical Device (Soonchunhyang University)

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
Richmond (USC)
Presenter :
Hyeonho Kim
(MFDS)

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
Miller (Roche)
Presenter: Jeff
Boone(Roche)

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
Sub Lim (SCL)
Presenter:
Hyuk Min Lee
(Yonsei University)