장은서 Email & Phone Number

대한민국 경기도

1. IVD reagent approval- New registration > class 1 : 3 completed > class 2 : 8 complted (flow cytometry) > class 3 : 1 complted (high-risk infectious test reagent)- Change registration for class 1~3 IVD product (major, minor)2. KGMP initial and regular audit- 7 regular document audits (2 grade 3, 5 grade 2)- 1 initial documen audit (2 grade)- 1 on-site regular audit (3 grade)3. Chemical management- Issuance and management of chemical import confirmation statement- Creating and managing MSDS4. Others- post-market surveillance of IVD (reporting of side effects (recalls etc.))- Designated as a rare IVD- Insurance fee-related work (confirmation of existing technology, confirmation of new medical technology)- Creation and management of GSP documents

1. IVD reagent (grade 3) Domestic approval1) Work performance- Domestic approval of high-risk infectious test reagent (1 completed, 1 in progress)- Major license change of high-risk infectious test reagent- Minor license changes of IVD products- Permission for export of high-risk infectious test reagent (3 completed)2) Main role: Preparation and review of technical documents, supplementary response to MFDS review, preparation and review of user manual (IFU), preparation of product label, preparation and review of development history, calculation of number of clinical samples, establishment of performance test (analytical, clinical, stability) standards, and Test monitoring & report writing2. Preparation of overseas registration data for IVD reagents (grade 3)1) Work performance- CE IVDD registration and change (class: others)- Prepare other foreign registration documents (Philippines, Vietnam, Brazil)2) Main role: Preparation of registration documents such as writing CE TCF, writing IFU in English, writing report in English, etc.3. KGMP and ISO13485 certified1) Work performance- KGMP change audit (item group addition)- ISO13485 change audit and regular audit2) Main role: Review response and preparation of supplementary materials, revision of quality manual and quality procedures, creation and revision of management ledger and form, UDI-DI management, creation of CAPA, creation and management of in vitro diagnostic medical device files.