Subject : Clinical Evaluation - 2021

Clinical evidence and clinical evaluation

Simon Singer ┃ TGA

103 views

Subject : Clinical Evaluation - 2021

Clinical investigation for medical devices: IMDRF’s principles

Frances Richmond ┃ USC

112 views

Subject : Clinical Evaluation - 2021

Clinical investigation: Best practices

Jaesoon Choi ┃ Asan Medical Center

63 views

Subject : Clinical Evaluation - 2020

Lecture : Clinical evaluation and evidence for medical devices

Greg LeBlanc ┃ Cook Medical

102 views

Subject : Clinical Evaluation - 2020

Lecture : Clinical evaluation and evidence for IVD medical devices

Hwan Sub Lim ┃ Seoul Clinical Laboratories

81 views

Subject 2. Risk Management - 2021

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

Jos Van Vroonhoven ┃ Philips

35 views

Subject 2. Risk Management - 2021

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

Eric Woo ┃ ECRI

36 views

Subject 2. Quality Management System - 2020

Lecture : Overview of ISO13485/2016

Yong Ho Lee ┃ SGS Korea

46 views

Subject 2. Quality Management System - 2020

Lecture : General Understanding of Medical Device Single Audit Program

Doug Reimer ┃ J&J

30 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

147 views

Subject 2. Quality Management System - 2020

Best practice : Medical Device Manufacturer Perspectives ‐ ISO 13485

Sun Young Jeong ┃ SD Biosensor

160 views

Subject 2. Quality Management System - 2020

Best practice : Medical Device Manufacturer Perspectives ‐ MDSAP

Doug Reimer ┃ J&J

167 views

Subject 3. Medical Device Vigilance - 2021

Generation of data related to the use of medical devices

Hiroshi Ishikawa ┃ PMDA

44 views

Subject 3. Medical Device Vigilance - 2020

Lecture : Introduction to Medical Device Adverse Events

Naoki Morooka ┃ JIRA

40 views

Subject 3. Medical Device Vigilance - 2020

Lecture : IMDRF Terms & Codes

Ishikawa Hiroshi ┃ PMDA

51 views

Subject 3. Medical Device Vigilance - 2020

Lecture : Exploration of IMDRF Adverse Event Terminology Web Browser

Ishikawa Hiroshi ┃ PMDA

34 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

40 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

32 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

67 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

62 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

162 views