- 경력 15년 이상
- NB 심사원 경력
- CE MDD/MDR/IVDR 포함 CE 지도 약 200건 이상
- 510(k), QSR, EUA, Pre-Submission 포함 FDA 지도 약 70건 이상
- 품목신고, 품목인증, 품목허가, GMP, 안전정보원 등 MFDS 지도 약 50건 이상
- ISO 13485, ISO 22716, GMP, CEN TR 17223, QSR/QMSR, MDSAP 포함 시스템 지도 약 100건 이상
- ISO 10993 생체적합성 시험, 화학적특성화 시험 등 생물학적 시험 지도 약 300건 이상
- FDA, CE, MFDS 사이버보안 10건 이상
실제 상담후기
- “상담을 상세히 잘해주셨어요.”
- “피부미용 관련 품목에 전문성이 정말 높아요!.”
컨설팅 이력_CE
| No | 품목명 | 인증명 |
|---|---|---|
| 1 | Anti-Adhesion Barrier Gel (Korea) | CE MDR |
| 2 | Handheld Ultrasound Scanners (Korea) | CE MDR |
| 3 | Surgical Battery Power Tools | CE MDR |
| 4 | Sterile Single Use Polydioxanone Suture with Needle | MDSAP |
| 5 | Medical Brace (Korea) | CE MDD |
| 6 | Rehabilitation Glove (Korea) | CE MDD |
| 7 | Sequential Compression Device (Korea) | CE MDD |
| 8 | High Intensity Focused Ultrasound | CE MDD |
| 9 | Soft contact Lens (Korea) | CE MDD, QMS |
| 10 | Hyaluronan Soft Filling Gel (Germany) | CE MDD |
| 11 | Sterile Polyglycolic Acid (PGA) Absorbable suture with/without Needle (China) | CE MDD |
| 12 | Sterile single use absorbable polydioxanone suture with needle (Korea) | CE MDD |
| 13 | Insulin Syringe (Korea) | CE MDD |
| 14 | Hyaluronan Soft Filling Gel (Italy) | CE MDD |
| 15 | Hemostatic Dressing & Interventional Hemostatic Pad (Korea) | CE MDD |
| 16 | Absorbable Adhesion Barrier (Korea) | CE MDD |
| 17 | Medical Mask (Korea) | CE MDD |
| 18 | LED (Light Emitting Diode) Phototherapy device (Korea) | CE MDD |
| 19 | Surgical Skin Closure (Korea) | CE MDD, QMS |
| 20 | Cross-linked Hyaluronic Acid with Lidocaine and Polynucleotide (Korea) | CE MDD, QMS |
| 21 | Polynucleotide Dermal injection with Lidocaine (Korea) | CE MDD, QMS |
| 22 | Total Hip Implant System (Korea) | CE MDD |
| 23 | General Purpose Catheter (Korea) | CE MDD |
| 24 | Sterile Intravascular catheter (Korea) | CE MDD |
| 25 | Cross-linked Hyaluronic Acid (Korea) | CE MDD |
| 26 | Cross-linked Hyaluronic Acid with Lidocaine (Korea) | CE MDD |
| 27 | Hyaluronan Soft Filling Gel (Switzerland) | CE MDD |
| 28 | Hyaluronan Soft Filling Gel (France) | CE MDD |
| 29 | Cross-linked Hyaluronic Acid with Lidocaine (Korea) | CE MDD |
| 30 | Sterile single use absorbable polydioxanone suture with needle (Korea) | CE MDD |
| 31 | Sodium Hyaluronate, Cross-Linked: Hyaluronic Soft Tissue Filling Gel (UK) | CE MDD |
| 32 | Cross-linked Hyaluronic Acid Dermal Filler with Lidocaine (Korea) | CE MDD |
| 33 | Shoulder Joint System (Korea) | CE MDD |
| 34 | Total Knee Replacement System (Korea) | CE MDD |
| 35 | Spinal Fixation System (Korea) | CE MDD |
| 36 | Reusable surgical instrument (Korea) | CE MDD |
| 37 | Polycaprolactone Injectable Implant (Korea) | CE MDD |
| 38 | Sterile, Single use Surgical Stapler – Manual (Korea) | CE MDD |
| 39 | Sterile, Single use Surgical Stapler – Automatic (Korea) | CE MDD |
| 40 | Sterile, Single use Biopsy Needle with Trocar (Korea) | CE MDD |
| 41 | Sterile, Single use Biopsy Auto Needle (Korea) | CE MDD |
| 42 | Sterile, Singe use Cartridge Loaded with Non-Absorbable Surgical Titanium Clip (Korea) | CE MDD |
| 43 | Sterile, Singe use Cartridge Loaded with Non-Absorbable Surgical Polymer Clip (Korea) | CE MDD |
| 44 | Absorbable Oxidized Regenerated Cellulose Hemostat (China) | CE MDD |
| 45 | Hyaluronan Soft Filling Gel (Estonia) | CE MDD |
| 46 | Hyaluronan Soft Filling Gel (Germany) | CE MDD |
| 47 | Hyaluronan Soft Filling Gel (U.S.) | CE MDD |
| 48 | Hyaluronan Soft Filling Gel (China) | CE MDD |
| 49 | Dental Implant (Korea) | CE MDD |
| 50 | Single use medical swab for specimen collection (Korea) | CE MDD |
| 51 | Vaginitis Treatment Device (Korea) | CE MDD |
| 52 | Immunofluorescence measuring device (Korea) | CE IVDD |
| 53 | COVID-19 IgM/IgG Rapid Kit (Korea) | CE IVDD |
| 54 | Novel Coronavirus detection kit (Korea) | CE IVDD |
| 55 | Nucleic Acid Isolation Kit (Korea) | CE IVDD |
| 56 | Anticancer drug respond predicting software (Korea) | CE IVDD |
컨설팅 이력_FDA
| No | 품목명 | 인증명 |
|---|---|---|
| 1 | Orthodontic plastic bracket | FDA 510(k) |
| 2 | Compressible Limb Sleeve | FDA 510(k) |
| 3 | Reagents, 2019-Novel Coronavirus Nucleic Acid | FDA EUA |
| 4 | Reagents, 2019-Novel Coronavirus Nucleic Acid | FDA EUA |
| 5 | Polymer Patient Examination Glove | FDA 510(k) |
| 6 | Device, Anti-Snoring | FDA 510(k) |
| 7 | Extraoral source x-ray system | FDA 510(k) |
| 8 | Bone grafting material | FDA 510(k) |
| 9 | Absorbable poly(glycolide/l-lactide) surgical suture | FDA 510(k) |
| 10 | Implant, Endosseous, Root-Form | FDA 510(k) |
| 11 | Abutment, Implant, Dental, Endosseous | FDA 510(k) |
| 12 | Endosseous dental implant abutment | FDA 510(k) |
| 13 | System, Image Processing, Radiological | FDA 510(k) |
| 14 | Radiological Imaging Software | FDA 510(k) |
| 15 | Platelet And Plasma Separator For Bone Graft Handling | FDA 510(k) |
| 16 | Picture archiving and communications system | FDA 510(k) |
| 17 | fastener, fixation, non-biodegradable, soft tissue | FDA 510(k) |
| 18 | Smooth or threaded metallic bone fixation fastener | FDA 510(k) |
| 19 | Preformed Alterable Cranioplasty Plate; Burr hole cover; Cranioplasty plate fastener | FDA 510(k) |
| 20 | Implant, Endosseous, Orthodontic | FDA 510(k) |
| 21 | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA 510(k) |
| 22 | External Mandibular Fixator And/Or Distractor | FDA 510(k) |
| 23 | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FDA 510(k) |
| 24 | Lenses, Soft Contact, Daily Wear | FDA 510(k) |
| 25 | Suture, Surgical, Absorbable, Polydioxanone | FDA 510(k) |
| 26 | Gastrointesinal Lesion Software Detection System | FDA 510(k) |
| 27 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA 510(k) |
| 28 | Barrier, Animal Source, Intraoral | FDA 510(k) |
| 29 | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA 510(k) |
| 30 | Suture, Nonabsorbable, Synthetic, Polyamide | FDA 510(k) |
| 31 | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA 510(k) |
| 32 | Electrosurgical, Cutting & Coagulation & Accessories | FDA 510(k) |
| 33 | Software Algorithm Device To Assist Users In Digital Pathology | Pre-Submission |
| 34 | Bone grafting material. | Pre-Submission |
| 35 | Stent, Metallic, Expandable, Duodenal | FDA QSR |
| 36 | Soft (hydrophilic) Contact Lens | FDA QSR |
| 37 | Needle, hypodermic, single lumen | FDA QSR |
| 38 | Absorbable suture | FDA QSR |
| 39 | System, X-Ray, Stationary | FDA QSR |
| 40 | System, Image Processing, Radiological | FDA QSR |
| 41 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA QSR |
| 42 | Grid, Radiographic | FDA QSR |
| 43 | Screen, Intensifying, Radiographic | FDA QSR |
| 44 | Wireless Electrocardiogram Patch | FDA QSR |
| 45 | ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) | FDA QSR |
| 46 | LifeSignals Multi-parameter Remote Monitoring Platform | FDA QSR |
| 47 | Pad, Menstrual, Unscented | FDA QSR |
| 48 | Garment, Protective, For Incontinence | FDA QSR |
| 49 | fastener, fixation, non-biodegradable, soft tissue | FDA QSR |
| 50 | Smooth or threaded metallic bone fixation fastener | FDA QSR |
컨설팅 이력_MFDS
| No | 품목명 | 인증명 |
|---|---|---|
| 1 | 심리요법용뇌용전기자극장치 | 품목허가 |
| 2 | 이학진료용기구 | 품목인증 |
| 3 | 연성내시경용세정소독기 | GMP |
| 4 | 유전질환검사시약 | GMP |
| 5 | 의료영상전송장치소프트웨어 | 품목인증, GMP |
| 6 | ERP 소프트웨어 | GMP |
| 7 | 의료용압력분산매트리스 | GMP |
| 8 | 지혈대, 탄력밴드 | 품목신고 |
| 9 | 치과교정장치용레진 | 품목인증 |
| 10 | 주사기, 주사침류, 생체현상측정기기 | GMP |
| 11 | 전동식의약품혼합용기구 | 품목인증, GMP |
| 12 | 재사용가능천자침 | 품목신고 |
| 13 | 귀적외선체온계, 자동전자혈압계, 심박수계, 초음파흡입기 | GMP |
| 14 | 치아미백용광선조사기 | GMP |
| 15 | 지방분리용기구 | GMP |
| 16 | 생체검사용도구한벌 | 품목인증 |
| 17 | 콜라겐사용조직보충재 | GMP |
| 18 | 개인용체외진단검사시약Ⅰ | 품목인증 |
| 19 | 다수 품목 | 안전정보원 |
| 20 | 고위험성감염체유전자검사시약 | 품목허가, GMP |
| 21 | 일회용내시경겸자, 일회용발조절식전기수술기용전극 | 품목인증, GMP |
| 22 | 심미치관재료 | 품목인증, GMP |
| 23 | 항암제감수성검사 소프트웨어 | 품목인증, GMP |
| 24 | 실시간유전자증폭장치 | GMP |
| 25 | 의료용온습도조절기 | GMP |
| 26 | 점착성투명창상피복재 | GMP |
| 27 | 치경, 의료용충전기, 의료용천자기, 흡인용튜브카테터, 성형된치관, 비금속제근관포스트, 금속제근관포스트 | GMP |
| 28 | 검체수송배지 | GMP |
| 29 | 흡수성합성폴리머재료 | 품목허가, GMP |
| 30 | 일회용수동식의료용칼 | 품목인증, GMP |
| 31 | 확장용의료용흡인기 | GMP |
| 32 | 운반형인공호흡기 | GMP |
| 33 | 재사용가능요실금용클램프 | 품목신고 |
이런 장점이 있어요.
- CE MDR, CE IVDR, FDA De Novo, FDA 510(k), MFDS, 인도
- KGMP, ISO 13485, MDSAP, CEN TR 17223, FDA QMSR
- ISO 10993 생체적합성 시험, 화학적특성화 시험, 독성학적 위험 평가, 생물학적 위험 평가, 독성동태학, 생분해성시험
- NIDS, 중소벤처기업부, NSAI, TCL, UDEM 등 다수의 협력 기관
- 의료기기 제조물배상책임보험 (PL 보험)
- 미국 및 유럽 대리인
- 자율 판매 증명서 발급
- EUDAMED 등록 및 SRN 발급
- 해외규격시험
- IEC 60601-1 규격문서(Usability, SW Validation, RM)
- 프로세스 위험관리
- 사전 심사 혹은 3자 심사
- 번역 및 통역
위치
- 서울시 금천구
