인허가 컨설팅
(RA Service)
Medical device RA consulting scope
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Regulatory affairs service
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Comprehensive consulting planning
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MDR, MDD, IVDR, US FDA 510K
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MFDS (Ministry of Food and Drug Safety, Korea)
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Overseas registration support
MDR, MDD, IVDR, US FDA 510K ,
MFDS (국내 식약처) 와
해외인증 지원 컨설팅서비스를
제공하고 있습니다.
MDR, MDD, IVDR, US FDA 510K, MFDS and overseas certification support consulting services.
품질관리 컨설팅
(QA Service)
Medical device QA consulting scope
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Quality assurance service
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Comprehensive consulting planning
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KGMP (Korea GMP), ISO 13485, MDSAP
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Overseas quality assurance requirements support
KGMP, ISO 13485, MDSAP, 수입 GMP,
해외 품질요구사항 지원 컨설팅서비스를
제공하고 있습니다.
We provide consulting services to support KGMP, ISO 13485, MDSAP, imported GMP, and overseas quality requirements.
대리인서비스
(Representative Service)
Medical device representative service
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Connecting with a qualified representative service
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Communication with representative service (English, Korean only)
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Korea, USA, Europe, China
당사와 파트너 쉽을 맺은 유럽, 미국,
중국 현지 대리인 서비스를 제공하는
업체와의 계약 및 소통서비스를
제공하고 있습니다.
We facilitate seamless connections between our company and our trusted partners in Europe, the United States, and China. Our core service offering includes contract management and communication services with local representatives.
서비스 (Service)
전문 지식, 풍부한 경험, 그리고 그를 뛰어넘는 고객에 대한 관심과 배려
Expertise, rich experience, and concern and consideration for customers beyond that