Projects
| PI | Title | Research order |
|---|---|---|
| Choi SJ | Medical Device Safety Monitoring Center(2024-2026) | NIDS |
| Lee YK | Healthcare Experts’ Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea: Introduction of Clinical Unmet Needs-Based Intended Use Establishment (CLUE) Templates(2024-2025) | SCH |
| Choi SJ | A questionnaire survey on the diagnosis and treatment of Fabry nephropathy in clinical practice(2023-2024) | SCH |
| Choi SJ | Preparation of Educational Materials for the Implementation of Harmonized International Standard Codes for Adverse Events(2023) | MFDS |
| Lee YK | Adopting a new project in ISO of the clinical perspective design template for medical device developer(2023-2025) |
KMDF |
| Lee YK | Korean Clinical Practice Guidelines: Current Status of Adherence to the RIGHT Checklist(2022-2023) | SCH |
| Kim JK | Medical Device Safety Monitoring Center(2021-2023) | NIDS |
| Choi SJ | The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience(2021-2022) | SCH |
| Lee YK | Development of the International Standard for Maintaining Proper Quality of In Vitro Diagnostic Inspection Service in the Infectious Disaster(2021-2024) | KEIT |
| Lee YK | Development of the International Standard for the Facilitate Emergency Use and Proper Supply of In Vitro Diagnostic Medical Devices in the Infectious Disaster(2021-2024) | KEIT |
| Lee YK | 21173미래기245_A study on the basis of active information collecting system for medical device adverse event using common data model (2021-2023) | MFDS |
| Choi SJ | A Study on International Harmonization of Standard Code for Medical Device Adverse Event (2021) | MFDS |
| Lee YK | Innovative Technologies and Medical Care of Next Generations(2021) | SCH |
| Lee YK | AHC-SCH Center of Excellence in Medical Device (2020-) | AHC |
| Lee YK | 20013839_International Standard for Emergency Use Approval and Post-marketing Safety Monitoring In-vitro Diagnosis Medical Devices in an infectious disease disaster (2020-2021) | KEIT |
| Lee YK | 20013842_ An international standard for quality requirements of a clinical laboratory under the circumstance of EUA in vitro diagnostic devices use (2020-2021) | KEIT |
| Lee YK | 20172미래기362_ A Study on the Utilization Plan of Common Data Model for Activation Report of Medical Device Side Effects (2020) | MFDS |
| Lee YK | 2020 Medical Device Safety Monitoring Center (2020) | NIDS |
| Lee YK | 2019 Medical Device Safety Monitoring Center (2019) | NIDS |
| Lee YK | 19172안전화297_A Study on International Harmonization for Medical Device Adverse Event Safety Information Management System (2019) | MFDS |
| Lee YK | 18172안전선286_ A Study on Developing Safety Technology by International Harmonization for Medical Device Vigilance Monitoring System (2018) | MFDS |
| Lee YK | 2018 Medical Device Safety Monitoring Center (2018) | NIDS |
| Lee YK | 2017 Medical Device Safety Monitoring Center (2017) | NIDS |
| Lee YK | 2016 Medical Device Safety Monitoring Center (2016) | NIDS |
| Lee YK | 2015 Medical Device Safety Monitoring Center (2015) | NIDS |
| Lee YK | 2014 Medical Device Safety Monitoring Center (2014) | NIDS |
| Lee YK | 2013 Medical Device Safety Monitoring Center (2013) | NIDS |
Abbreviation : MFDS, ministry of food and drug safety; SCH, soonchunhyang university; AHC, APEC harmonization center; KEIT, Korea evaluation institute of industrial technology.