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CE IVDRCE MDRFDAISO 13485KGMPMFDS

W&W RAQA

By 11월 29, 202411월 30th, 2024No Comments
  • 전문 컨설팅 회사
  • 4년 이상, 의료기기 RA,QA부서에서 근무한 경력이 있는 경력자들이 컨설팅 진행
  • 컨설팅 퀄리티 유지를 위해 소수의 컨설팅에 집중

컨설팅 이력

No 품목명 인증명
1 Spine fixation chair CE MDD
2 Specimen collector CE MDD
3 Dental accessories CE MDD
4 Orthodontic Ceramic Bracket CE MDD, ISO13485, GMP
5 Orthodontic Bracket & Wire CE MDD, ISO13485, GMP
6 PACS (Picture Archiving and Communication System) CE MDD, MDR, US FDA, ISO 13485, GMP
7 AI base X ray image Bone Age Assessment system CE MDD, ISO13485, GMP
8 AI base Computer-Aided Processing Software (Cardiac, Eye) CE MDR, ISO13485
9 Drug Infusion Monitor CE MDD, ISO13485
10 Micro needle CE MDD, ISO13485, GMP
11 Hair implant needle CE MDD
12 Infusion needle CE MDD, ISO13485
13 Sterile Platelet-Rich Plasma Blood Separation Kit CE MDD, ISO13485, GMP
14 Dental hand piece CE MDD
15 Ultrasonic irrigation CE MDD
16 Primary Crown CE MDD
17 Body Composition Analyzer CE MDD
18 Dental brush CE MDD, US FDA
19 Dental Engine for Implant Surgery CE MDR
20 Dental GBR system CE MDR
21 Facial silicone implant CE MDD, MDR, ISO13485, GMP
22 Drug Infusion Monitor CE MDR
23 Dental Abutment & Fixture CE MDD
24 Ceramic Abutment CE MDD
25 Focused Ultrasound Stimulator Use System CE MDR
26 Picosecond Nd:YAG Laser CE MDR
27 Radiological computer-assisted diagnostic software CE MDR
28 Orthopaedic Surgical Robot System CE MDR
29 PDO suture with Needle CE MDD, MDR, ISO13485, GMP
30 Hemostatic peel away introducer system for vascular access CE MDD, GMP
31 Staining reagent for cell and tissue pathology tests CE IVD
32 Influenza Rapid kit CE IVD, ISO13485
33 Malaria Rapid kit CE IVD, ISO13485
34 Dengue NS1 Rapid kit CE IVD, ISO13485
35 Rota,Adeno Rapid kit CE IVD, ISO13485
36 Cardiac diagnosis kit CE IVD, ISO13485
37 Troponin I diagnosis kit and etc CE IVD, ISO13485
38 PSA test CE IVD, ISO13485
39 Pregnancy test kit CE IVD, ISO13485
40 Spine cage US FDA
41 Intraoral camera US FDA
42 DNA analyzer US FDA
43 Spinal system US FDA
44 Dressing, Wound, Drug US FDA
45 Dental handpiece and accessories US FDA
46 Ear, Nose, And Throat Synthetic Polymer Material US FDA
47 Software used for medical imaging analysis (Breast cancer) US FDA
48 Software used for medical imaging analysis (Lung cancer) US FDA
49 Wound dressing MFDS
50 Specimen collector MFDS, ISO13485, GMP
51 Nucleic acid extractor MFDS
52 Vaginal endoscope MFDS
53 Endoscopic clip MFDS
54 Clinical Chemistry Analyzer MFDS, ISO13485
55 IVD analyzer for self-test MFDS
56 Urine chemistry test kit MFDS
57 Pregnancy test kit MFDS
58 CRP test kit and etc MFDS
59 COVID-19 Detection Kit MFDS, ISO13485, GMP
60 COVID 19 Ag Home Test MFDS, ISO13485, GMP
61 Dental implant MFDS
62 Lumbar Expandable Cage System MFDS
63 Hemostatic peel away introducer system for vascular access MFDS
64 Polydioxanone suture with needle MFDS, ISO13485, GMP
65 Cardiovascular stent MFDS
66 Facial silicone implant NMPA (China)
67 Cardiac diagnosis kit NMPA (China)
68 Troponin I diagnosis kit NMPA (China)
69 PSA test NMPA (China)
70 PDO suture with Needle NMPA (China), TFDA (Taipei)
71 Urine chemistry test kit ANVISA (Brazil)
72 Pregnancy test kit ANVISA (Brazil)
73 IVD analyzer for self-test ANVISA (Brazil)

이런 장점이 있어요.

  • MFDS, CE MDR, CE IVDR FDA
  • KGMP, ISO 13485
  • 대리인 서비스 등 전 분야 서비스 제공

위치

  • 경기도 수원시

 

선택이 어렵다면? 컨설턴트 추천받기

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W&W RAQA

  • 전문 컨설팅 회사
  • 4년 이상, 의료기기 RA,QA부서에서 근무한 경력이 있는 경력자들이 컨설팅 진행
  • 컨설팅 퀄리티 유지를 위해 소수의 컨설팅에 집중

컨설팅 이력

No 품목명 인증명
1 Spine fixation chair CE MDD
2 Specimen collector CE MDD
3 Dental accessories CE MDD
4 Orthodontic Ceramic Bracket CE MDD, ISO13485, GMP
5 Orthodontic Bracket & Wire CE MDD, ISO13485, GMP
6 PACS (Picture Archiving and Communication System) CE MDD, MDR, US FDA, ISO 13485, GMP
7 AI base X ray image Bone Age Assessment system CE MDD, ISO13485, GMP
8 AI base Computer-Aided Processing Software (Cardiac, Eye) CE MDR, ISO13485
9 Drug Infusion Monitor CE MDD, ISO13485
10 Micro needle CE MDD, ISO13485, GMP
11 Hair implant needle CE MDD
12 Infusion needle CE MDD, ISO13485
13 Sterile Platelet-Rich Plasma Blood Separation Kit CE MDD, ISO13485, GMP
14 Dental hand piece CE MDD
15 Ultrasonic irrigation CE MDD
16 Primary Crown CE MDD
17 Body Composition Analyzer CE MDD
18 Dental brush CE MDD, US FDA
19 Dental Engine for Implant Surgery CE MDR
20 Dental GBR system CE MDR
21 Facial silicone implant CE MDD, MDR, ISO13485, GMP
22 Drug Infusion Monitor CE MDR
23 Dental Abutment & Fixture CE MDD
24 Ceramic Abutment CE MDD
25 Focused Ultrasound Stimulator Use System CE MDR
26 Picosecond Nd:YAG Laser CE MDR
27 Radiological computer-assisted diagnostic software CE MDR
28 Orthopaedic Surgical Robot System CE MDR
29 PDO suture with Needle CE MDD, MDR, ISO13485, GMP
30 Hemostatic peel away introducer system for vascular access CE MDD, GMP
31 Staining reagent for cell and tissue pathology tests CE IVD
32 Influenza Rapid kit CE IVD, ISO13485
33 Malaria Rapid kit CE IVD, ISO13485
34 Dengue NS1 Rapid kit CE IVD, ISO13485
35 Rota,Adeno Rapid kit CE IVD, ISO13485
36 Cardiac diagnosis kit CE IVD, ISO13485
37 Troponin I diagnosis kit and etc CE IVD, ISO13485
38 PSA test CE IVD, ISO13485
39 Pregnancy test kit CE IVD, ISO13485
40 Spine cage US FDA
41 Intraoral camera US FDA
42 DNA analyzer US FDA
43 Spinal system US FDA
44 Dressing, Wound, Drug US FDA
45 Dental handpiece and accessories US FDA
46 Ear, Nose, And Throat Synthetic Polymer Material US FDA
47 Software used for medical imaging analysis (Breast cancer) US FDA
48 Software used for medical imaging analysis (Lung cancer) US FDA
49 Wound dressing MFDS
50 Specimen collector MFDS, ISO13485, GMP
51 Nucleic acid extractor MFDS
52 Vaginal endoscope MFDS
53 Endoscopic clip MFDS
54 Clinical Chemistry Analyzer MFDS, ISO13485
55 IVD analyzer for self-test MFDS
56 Urine chemistry test kit MFDS
57 Pregnancy test kit MFDS
58 CRP test kit and etc MFDS
59 COVID-19 Detection Kit MFDS, ISO13485, GMP
60 COVID 19 Ag Home Test MFDS, ISO13485, GMP
61 Dental implant MFDS
62 Lumbar Expandable Cage System MFDS
63 Hemostatic peel away introducer system for vascular access MFDS
64 Polydioxanone suture with needle MFDS, ISO13485, GMP
65 Cardiovascular stent MFDS
66 Facial silicone implant NMPA (China)
67 Cardiac diagnosis kit NMPA (China)
68 Troponin I diagnosis kit NMPA (China)
69 PSA test NMPA (China)
70 PDO suture with Needle NMPA (China), TFDA (Taipei)
71 Urine chemistry test kit ANVISA (Brazil)
72 Pregnancy test kit ANVISA (Brazil)
73 IVD analyzer for self-test ANVISA (Brazil)

이런 장점이 있어요.

  • MFDS, CE MDR, CE IVDR FDA
  • KGMP, ISO 13485
  • 대리인 서비스 등 전 분야 서비스 제공

위치

  • 경기도 수원시

 

선택이 어렵다면? 컨설턴트 추천받기