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CE IVDRCE MDRFDAISO 13485KGMPMDSAPMFDS기타국가

액트

By 11월 29, 20243월 31st, 2025No Comments
  • 일반 의료기기, 체외진단 의료기기, 의료용품 등 전 품목 컨설팅 가능
  • 미국 내 사용적합성 센터와의 협력 관계를 통해 FDA Human Factor Engineering 컨설팅 제공
  • 독점 OECD GLP 시험소를 통해 생체적합성,화학적 분석 등의 서비스 제공
  • 규격시험 동시 진행 가능 (Safety, EMC, RF 인증, NRTL, FCC 등)

실제 상담후기

  • “규격관련 상담을 잘해줘요”

컨설팅 이력

No 품목명 인증명
1 이동형,진단용, 디지털엑스선투시촬영장치 CE MDR, FDA, MDSAP, KGMP, cGMP
2 의료용캡슐내시경 cGMP, KGMP
3 전동식정형용운동장치 KGMP, MFDS, MDSAP, CE MDR
4 혈액처리용기구 (PRP) CE MDR
5 치과영상치료계획소프트웨어 MFDS, KGMP, FDA, CE MDD
6 고주파자극기 KGMP, MFDS
7 개인용조합자극기 KGMP, MFDS
8 환자감시장치 FDA, MFDS
9 홀터심전계 FDA, MFDS, CE MDR, KGMP
10 개인용온열기 KGMP, MFDS
11 골밀도 측정기 CE MDR
12 일회용발조절식전기수술기용전극 CE MDR
13 인슐린펌프 MFDS, CE MDD, KGMP
14 냉동수술기 KGMP, MFDS, CE MDD, FDA, NMPA
15 검안용굴절력측정기 FDA, cGMP, CE MDR
16 생체신호 분석소프트웨어 KGMP, MFDS, MDSAP
17 의료영상전송장치소프트웨어 KGMP, MFDS, FDA, CE MDD
18 각막내피수술기 KGMP
19 의료용산소발생기 MFDS, KGMP
20 가스식의약품주입펌프 KGMP
21 적외선조사기 MFDS, KGMP
22 의료용진동기 MFDS, KGMP
23 의료영상획득장치 MFDS, CE MDD, MDR, FDA
24 체성분분석기 MDSAP, cGMP
25 치과용임플란트고정체 ,상부구조물 KGMP, MFDS, CE MDD, FDA, NMPA
26 조직수복용생체재료 KGMP, MFDS, CE MDD
27 혈관내튜브카테터 KGMP, MFDS, CE MDD
28 이종골이식재 KGMP, MFDS, CE MDD
29 추간체유합보형재 KGMP, MFDS, CE MDD
30 골절합용판,나사 KGMP, MFDS, CE MDD

Biocompatibility test (ISO/USP/ASTM/ASTM/ANSI)

No 품목명
1 In vitro cytotoxicity test
2 In vitro cytotoxicity test - Agar diffusion method
3 In vitro cytotoxicity test - Filter diffusion method
4 Intracutaneous reactivity test
5 Skin irritation test
6 Vaginal irritation test without Histopathology
7 Skin sensitization test (GPMT method)
8 Acute systemic toxicity test
9 Material mediated pyrogen test
10 Ocular irritation test
11 Oral mucosa Irritation Test
12 Subacute/Subchronic (14 days) Systemic toxicity test
13 Subacute/Subchronic (28 days) Systemic toxicity test
14 Subacute/Subchronic (90 days) Systemic toxicity test
15 Subacute/Subchronic (90 days) Systemic Toxicity – Route of administration (Implantation)
16 Chronic systemic toxicity (26 Week’s)
17 Genotoxicity; Bacterial reverse mutation (Ames) test
18 Genotoxicity; Invitro Micronucleus test
19 Genotoxicity; In vivo micronucleus test
20 Genotoxicity; Chromosomal aberration test
21 Genotoxicity; Mouse Lymphoma Assay
22 Bone (13 weeks) Implantation test
23 Intramuscular (1 week) implantation Test - 7 days
24 Intramuscular (4 week’s) implantation Test - 28 days
25 Intramuscular (8 week’s) implantation Test - 60 days
26 Intramuscular (13 week’s) implantation Test - 90 days
27 Intramuscular (26 week’s) implantation Test - 180 days
28 Subcutaneous (1 week) implantation Test - 7 days
29 Subcutaneous (2 week) implantation Test - 14 days
30 Subcutaneous (4 week) implantation Test   - 28 days
31 Subcutaneous (8 week) implantation Test - 60 days
32 Subcutaneous (13 week’s) implantation Test - 90 days
33 Subcutaneous (26 weeks) implantation Test - 180 days
34 Hemolysis Test: ASTM Indirect Contact Method
35 Hemolysis Test: ASTM Direct Contact Method
36 Hemocompatibility : Coagulation: Determination of the Partial Thromboplastin Time (PTT)
37 Hemocompatibility : Platelet Activation Test (PF4)
38 Hemocompatibility : Complement Activation : 3 donors, Sc5b9
39 Hemocompatibility : Hematology : Platelet and Leukocyte Activation, 3 donors
40 Biological Evaluation Plan
41 Biological Safety Assessment report (Biological Evaluation Report), Toxicological Risk Assessment

Chemical characterization Analysis (ISO 10993, Part 18/USP)

No 품목명
1 Endotoxin Mediated Pyrogen Test / Chromogen-kinetic Method - LAL Validation
2 Endotoxin Mediated Pyrogen Test / Chromogen-kinetic Method - LAL Test
3 GC/MS Fingerprint - Extractable semi-volatile organic substances, Analytical exhaustive extraction, 3 extraction
4 ICP-MS/OES-Fingerprint - Extractable Metallic and Inorganic Ions, multiple extraction(3 steps), 1 extraction
5 Headspace GC/MS - Volatile organic substances, exhaustive extraction, 1st test item
6 HPLC-MS/UV (QTOF) Fingerprint – Extractable non volatile organic substances, Gravimetric Exhaustive extraction, 3 extraction

이런 장점이 있어요.

  • MFDS, CE MDR, CE IVDR, FDA
  • KGMP, ISO 13485, MDSAP
  • 기타국가 (TGA, ANVISA, Health Canada, PMDA, NMPA, Russia, SFDA)

위치

  • 경기도 수원시

 

선택이 어렵다면? 컨설턴트 추천받기

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액트

  • 일반 의료기기, 체외진단 의료기기, 의료용품 등 전 품목 컨설팅 가능
  • 미국 내 사용적합성 센터와의 협력 관계를 통해 FDA Human Factor Engineering 컨설팅 제공
  • 독점 OECD GLP 시험소를 통해 생체적합성,화학적 분석 등의 서비스 제공
  • 규격시험 동시 진행 가능 (Safety, EMC, RF 인증, NRTL, FCC 등)

실제 상담후기

  • "규격관련 상담을 잘해줘요"

컨설팅 이력

No 품목명 인증명
1 이동형,진단용, 디지털엑스선투시촬영장치 CE MDR, FDA, MDSAP, KGMP, cGMP
2 의료용캡슐내시경 cGMP, KGMP
3 전동식정형용운동장치 KGMP, MFDS, MDSAP, CE MDR
4 혈액처리용기구 (PRP) CE MDR
5 치과영상치료계획소프트웨어 MFDS, KGMP, FDA, CE MDD
6 고주파자극기 KGMP, MFDS
7 개인용조합자극기 KGMP, MFDS
8 환자감시장치 FDA, MFDS
9 홀터심전계 FDA, MFDS, CE MDR, KGMP
10 개인용온열기 KGMP, MFDS
11 골밀도 측정기 CE MDR
12 일회용발조절식전기수술기용전극 CE MDR
13 인슐린펌프 MFDS, CE MDD, KGMP
14 냉동수술기 KGMP, MFDS, CE MDD, FDA, NMPA
15 검안용굴절력측정기 FDA, cGMP, CE MDR
16 생체신호 분석소프트웨어 KGMP, MFDS, MDSAP
17 의료영상전송장치소프트웨어 KGMP, MFDS, FDA, CE MDD
18 각막내피수술기 KGMP
19 의료용산소발생기 MFDS, KGMP
20 가스식의약품주입펌프 KGMP
21 적외선조사기 MFDS, KGMP
22 의료용진동기 MFDS, KGMP
23 의료영상획득장치 MFDS, CE MDD, MDR, FDA
24 체성분분석기 MDSAP, cGMP
25 치과용임플란트고정체 ,상부구조물 KGMP, MFDS, CE MDD, FDA, NMPA
26 조직수복용생체재료 KGMP, MFDS, CE MDD
27 혈관내튜브카테터 KGMP, MFDS, CE MDD
28 이종골이식재 KGMP, MFDS, CE MDD
29 추간체유합보형재 KGMP, MFDS, CE MDD
30 골절합용판,나사 KGMP, MFDS, CE MDD

Biocompatibility test (ISO/USP/ASTM/ASTM/ANSI)

No 품목명
1 In vitro cytotoxicity test
2 In vitro cytotoxicity test - Agar diffusion method
3 In vitro cytotoxicity test - Filter diffusion method
4 Intracutaneous reactivity test
5 Skin irritation test
6 Vaginal irritation test without Histopathology
7 Skin sensitization test (GPMT method)
8 Acute systemic toxicity test
9 Material mediated pyrogen test
10 Ocular irritation test
11 Oral mucosa Irritation Test
12 Subacute/Subchronic (14 days) Systemic toxicity test
13 Subacute/Subchronic (28 days) Systemic toxicity test
14 Subacute/Subchronic (90 days) Systemic toxicity test
15 Subacute/Subchronic (90 days) Systemic Toxicity – Route of administration (Implantation)
16 Chronic systemic toxicity (26 Week’s)
17 Genotoxicity; Bacterial reverse mutation (Ames) test
18 Genotoxicity; Invitro Micronucleus test
19 Genotoxicity; In vivo micronucleus test
20 Genotoxicity; Chromosomal aberration test
21 Genotoxicity; Mouse Lymphoma Assay
22 Bone (13 weeks) Implantation test
23 Intramuscular (1 week) implantation Test - 7 days
24 Intramuscular (4 week’s) implantation Test - 28 days
25 Intramuscular (8 week’s) implantation Test - 60 days
26 Intramuscular (13 week’s) implantation Test - 90 days
27 Intramuscular (26 week’s) implantation Test - 180 days
28 Subcutaneous (1 week) implantation Test - 7 days
29 Subcutaneous (2 week) implantation Test - 14 days
30 Subcutaneous (4 week) implantation Test   - 28 days
31 Subcutaneous (8 week) implantation Test - 60 days
32 Subcutaneous (13 week’s) implantation Test - 90 days
33 Subcutaneous (26 weeks) implantation Test - 180 days
34 Hemolysis Test: ASTM Indirect Contact Method
35 Hemolysis Test: ASTM Direct Contact Method
36 Hemocompatibility : Coagulation: Determination of the Partial Thromboplastin Time (PTT)
37 Hemocompatibility : Platelet Activation Test (PF4)
38 Hemocompatibility : Complement Activation : 3 donors, Sc5b9
39 Hemocompatibility : Hematology : Platelet and Leukocyte Activation, 3 donors
40 Biological Evaluation Plan
41 Biological Safety Assessment report (Biological Evaluation Report), Toxicological Risk Assessment

Chemical characterization Analysis (ISO 10993, Part 18/USP)

No 품목명
1 Endotoxin Mediated Pyrogen Test / Chromogen-kinetic Method - LAL Validation
2 Endotoxin Mediated Pyrogen Test / Chromogen-kinetic Method - LAL Test
3 GC/MS Fingerprint - Extractable semi-volatile organic substances, Analytical exhaustive extraction, 3 extraction
4 ICP-MS/OES-Fingerprint - Extractable Metallic and Inorganic Ions, multiple extraction(3 steps), 1 extraction
5 Headspace GC/MS - Volatile organic substances, exhaustive extraction, 1st test item
6 HPLC-MS/UV (QTOF) Fingerprint – Extractable non volatile organic substances, Gravimetric Exhaustive extraction, 3 extraction

이런 장점이 있어요.

  • MFDS, CE MDR, CE IVDR, FDA
  • KGMP, ISO 13485, MDSAP
  • 기타국가 (TGA, ANVISA, Health Canada, PMDA, NMPA, Russia, SFDA)

위치

  • 경기도 수원시

 

선택이 어렵다면? 컨설턴트 추천받기