Subject : Clinical Evaluation - 2021

Clinical evidence and clinical evaluation

Simon Singer ┃ TGA

12 views

Subject : Clinical Evaluation - 2021

Clinical investigation for medical devices: IMDRF’s principles

Frances Richmond ┃ USC

8 views

Subject : Clinical Evaluation - 2021

Clinical investigation: Best practices

Jaesoon Choi ┃ Asan Medical Center

11 views

Subject : Clinical Evaluation - 2020

Lecture : Clinical evaluation and evidence for medical devices

Greg LeBlanc ┃ Cook Medical

55 views

Subject : Clinical Evaluation - 2020

Lecture : Clinical evaluation and evidence for IVD medical devices

Hwan Sub Lim ┃ Seoul Clinical Laboratories

45 views

Subject 2. Risk Management - 2021

Application of risk management for medical devices (ISO 14971: 2019)

Jos Van Vroonhoven ┃ Philips

5 views

Subject 2. Risk Management - 2021

Continuous quality improvement; medical devices adverse event and quality management system (GHTF SG3/N18: 2010)

Eric Woo ┃ ECRI

2 views

Subject 2. Quality Management System - 2020

Lecture : Overview of ISO13485/2016

Yong Ho Lee ┃ SGS Korea

17 views

Subject 2. Quality Management System - 2020

Lecture : General Understanding of Medical Device Single Audit Program

Doug Reimer ┃ J&J

7 views

Subject 2. Quality Management System - 2020

Lecture : MDV‐QMS intersection – Guidance on corrective action and preventive action and related QMS processes

Eric Woo ┃ ECRI

58 views

Subject 2. Quality Management System - 2020

Best practice : Medical Device Manufacturer Perspectives ‐ ISO 13485

Sun Young Jeong ┃ SD Biosensor

58 views

Subject 2. Quality Management System - 2020

Best practice : Medical Device Manufacturer Perspectives ‐ MDSAP

Doug Reimer ┃ J&J

61 views

Subject 3. Medical Device Vigilance - 2021

Generation of data related to the use of medical devices

Hiroshi Ishikawa ┃ PMDA

5 views

Subject 3. Medical Device Vigilance - 2020

Lecture : Introduction to Medical Device Adverse Events

Naoki Morooka ┃ JIRA

11 views

Subject 3. Medical Device Vigilance - 2020

Lecture : IMDRF Terms & Codes

Ishikawa Hiroshi ┃ PMDA

13 views

Subject 3. Medical Device Vigilance - 2020

Lecture : Exploration of IMDRF Adverse Event Terminology Web Browser

Ishikawa Hiroshi ┃ PMDA

10 views

Untact Conference : September 10th 9AM (KST) - 2021

- Introduction of SCH CoE
- Q&A and Panel discussion on Clinical evaluation

Moderator: Frances Richmond ┃ USC

Presenter: Cheryl Hergert ┃ USC

5 views

Untact Conference : September 17th 9AM (KST) - 2021

- Sharing results of virtual hands-on activity
- Q&A and Panel discussion on IMDRF AE terminology & Risk Management
- Final Remarks from Program Committee

Moderator: Hwan Sub Lim ┃

Presenter: Patrick Revelle ┃ MedDRA

3 views

Untact Conference : November 3th 10AM (KST) - 2020

- Practical application of clinical evaluation in COVID-19

Moderator: Frances Richmond ┃ University of Southern California

Presenter: Hyeonho Kim ┃ MFDS

25 views

Untact Conference : November 10th 10AM (KST) - 2020

- Practical application of QMS in COVID-19 realtime PCR Manufacture

Moderator: Danelle Miller ┃ Roche

Presenter: Jeff Boone ┃ Roche

13 views

Untact Conference : November 17th 10AM (KST) - 2020

- In Vitro Diagnostic Device in Laboratory Practice
- Experience for COVID-19 realtime PCR

Moderator: Hwan Sub Lim ┃ Seoul Clinical Laboratories

Presenter: Hyuk Min Lee ┃ Yonsei University-Severance

60 views