회사 소개
INTRODUCING
CEO 이종은
대표 컨설턴트
MD QMS, KGMP, FDA, CE MDR 인증 전문가
2002 ~ 2021
안과의료기기, 심장충격기, 미용의료기기,
임플란트 의료기기 CE, 식약처 인허가 진행
2021 ~ 2022
(주)아큐레시스바이오: 체외진단 의료기기 식약처 인허가 진행
국내 의료기기 제조사 국내, 해외 인허가 진행
국내 의료기기 2개 임상 프로젝트 진행
ISO13485, 9001, 14001, 27001 심사원,
품질경영기사, 경영분석전문가
SANGJI UNIVERSITY MASTER
“ELECTRONIC” (2012)
PUKYONG NATIONAL UNIVERSITY
BACHELOR “MSE” (1995)
WE ARE GAON MEDICAL
CONSULTING
가온은 순 우리말로, '중간 또는 가운데' 라는 뜻으로
세상의 중심이 되겠다는 의미를 가지고 있습니다.
GAONMEDICAL CONSULTING serves some pharmaceutical
clients too, but its primary expertise lies in the
medical device space.
Founder and President has a wealth of industry
experience (20+ years), including a Quality Director role
for Cambridge-based Common Sensing.
The GAONMEDICAL CONSULTING team offer
targeted expert services around:
• QMS building and support (QMS gap analysis)
• Regulatory compliance with key standards like
ISO 13485 and FDA 21 CFR 820
• KGMP
• The MDSAP
• Risk management
• Audit readiness
• Internal audits
• Preparing submissions for regulatory approvals
• 510(k) submission
• EU MDR CE marking
• Technical File creation
• ANVISA, SFDA, R-GOST, PMDA, CMDCAS
• Optimizing medical device design and development
• Manufacturing and technical operations
• Outsourcing and supply chain
• Packaging and shipping
• Product and technology assessments
• Handling research of relevant literature
for product development