SeungHyun Lee

QMS Auditor (ISO13485, MDR, MDSAP, UKCA)

1) Technical documentation - Managing DHF   ㅁ Documentation (Risk management, CER, Biocompatibility, ER checklist, etc.)   ㅁ Validation (Gamma sterile, Shelf-life)   ㅁ Process control (Design change, SOP documents) 2) Pre/Post-clinical Follow-up - Pre-clinical follow-up (organization and data collection) - Usability report based on clinical data - Post-market clinical follow-up (data collection and documentation) 3) Expandable Interbody Fusion Device(Titanium), sterile/non-sterile - Shelf-life of packaging and gamma sterilization validation - Mechanical test of intervertebral body fusion devices   ㅁ Static/Dynamic compression test   ㅁ Static/Dynamic torsion test   ㅁ Static/Dynamic compression shear test   ㅁ Subsidence test 4) Regulatory Affairs - Internal CAPA follow-up - Experience surveillance audit for ISO 13485 and MDD (DNV, SZU) - Experience MDR trainsition with SZU (2024)

1) Documentation and validation - Risk management files, CER, PMS, PMCF, PSUR - Biological evaluation report, label specification - Sterilization validation(Steam) 2) Spinal fixation system, non-sterile - Mechanical test of spinal implant constructs ㅁ Static compression bending test/torsion test ㅁ Compression bending fatigue test - Mechanical test of spinal arthrodesis implants ㅁ Axial gripping capacity/Axial torque gripping capacity test 3) Intervertebral body fusion device(PEEK), sterile/non-sterile - Shelf-life of packaging and gamma-sterilization validation - Mechanical test of intervertebral body fusion devices ㅁ Static/Dynamic compression test ㅁ Static/Dynamic torsion test ㅁ Static compression shear test ㅁ Subsidence test 4) Bone screw(Trauma implant), non-sterile - Mechanical test of a bone screw ㅁ Static 3-point bending test 5) Regulatory Affairs - Experience surveillance audit for ISO 13485 and MDD (DNV) - Registration for intervertebral body fusion device (CE, FDA, MFDS)

1) Nitinol implant verification - Mechanical test for implants ㅁ Static compression bending test ㅁ Static tensile bending test ㅁ Compression bending fatigue test - Verification of material for Ti-Ni wire ㅁ Mechanical properties (tensile strength) ㅁ Chemical properties 2) Regulatory Affairs - Experience surveillance audit for ISO 13485 and MDD (SGS)

- Social network service - Marketing assistant

1. Marketing Assistant at Wabble; a Social contribution company - Social marketing about Wabble - Organizing events on social network 2. Member of the Student Union - Organizing events for students; membership training, students welfare event, accounting management 3. Mentor of Korea Scholarship Foundation - Organizing mentoring program for high school students - Teaching & advising high school students