- 의료기기 컨설팅 전문가 그룹 (Medical Device Consulting Expert Group)
- 풍부한 심사 및 현장 지도 경험을 바탕으로 컨설팅 진행
- US. Agent, EU Representative 서비스 제공
- ISO 13485 선임 심사원 출신
컨설팅 이력
| No | 품목명 |
|---|---|
| 1 | Non-sterile cervical brush |
| 2 | Mobile General-purpose Fluoroscopic X-ray System, Digital |
| 3 | Specimen Collection Swab |
| 4 | Coronavirus antigen detection test system |
| 5 | Needle, acupuncture, single use |
| 6 | Non-sterile medical face mask |
| 7 | Dental Surgical Guide Resin |
| 8 | Retainer, Mouthpiece, Nightguard |
| 9 | Dental Implant System (Fixture, Abutment) |
| 10 | Preformed Crown & Bridger |
| 11 | Polymer Ligation Locking Clip |
이런 장점이 있어요.
- MFDS, CE MDR, CE IVDR, FDA
- KGMP, ISO 13485
- 인허가 컨설팅 외 규격 시험 및 벨리데이션 진행
- Device Testing : Safety, Biocompatibility & Toxicology, Extractables & Leachables, Biological Evaluation
- Ptocess Validation : Facility & Process Validation, Sterilizatioon, Packaging and Transit (Transport), Stability (Shelf-life)
- Sterilization Validation : Ethylene oxide, Radiation, Moist heat
위치
- 서울시 동작구
