최소 단어 이상 선택하여야 합니다.
최대 10 단어까지만 선택 가능합니다.
다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
NTIS 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
DataON 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
Edison 바로가기다음과 같은 기능을 한번의 로그인으로 사용 할 수 있습니다.
Kafe 바로가기주관연구기관 | 의료기기정보기술지원센터 |
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연구책임자 | 이종록 |
참여연구자 | 김승종 , 정선영 , 한지만 |
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 | 한국어 |
발행년월 | 2016-08 |
주관부처 | 미래창조과학부 Ministry of Science, ICT and Future Planning |
등록번호 | TRKO201800006921 |
DB 구축일자 | 2018-05-19 |
키워드 | 의료기기 인허가.인허가 로드맵.전주기 개발지원.성과확산.기술교류.Product development.Design of product.Good manufacturing practice.Product Testing.Product Approval. |
○ 제품개발계획 및 제품설계, 기준규격, GMP 관련 인허가 정보, 임상시험 등 정보·기술 지원
○ 연구과제별 인허가 로드맵 설계 및 맞춤형 인허가 가이드라인 개발을 통한인허가 추진현황 모니터링
○ 규격, 디자인, 기구설계, 금형, 사용자로 구성된 전문가 pool을 구성하여 디자인/Mock-up 품평회 개최
○ 개발제품에 대한 글로벌 업체 및 수요자 대상 성과확산을 위한 산학연병 기술교류 세미나 개최
(출처 : 보고서 요약서 3p)
Purpose & Contents
○ The ultimate goal of this Substudy 1 is to organize a professional task force responsible for the R&D study support project assist constantly the selected enterprises for studies for the new-market-creating next-generation medical device development project in a variety of re
Purpose & Contents
○ The ultimate goal of this Substudy 1 is to organize a professional task force responsible for the R&D study support project assist constantly the selected enterprises for studies for the new-market-creating next-generation medical device development project in a variety of regulatory and business affairs ranging from product development to acquisition of regulatory authorities’ clearance/approval, including medical device approval, patent application, marketing information/skills, and administrative affairs; identify any troubles or problems in R&D activities in cooperation with KIST (Substudy 2) to prepare promptly their solutions; and, contribute substantially to successful R&D efforts through progress management for the sake of achievement of annual study goals.
Results
○ To publish weekly updates and make research reports on the trend of medical devices and industry in order to provide information about latest standards and guidelines of each country and currently conducted R&Ds
○ To provide assistance with product development, designs, and technology through written papers and on-site visits
○To hold seminars and training courses for product development, validation, quality control, patents and project management, etc. to enhance capacity of project researchers
○ To monitor current progress status of each research project by establishing the secretariat and acquiring staff in charge for smooth project operation
Expected Contribution
○ To expand possibilities of rapid product commercialization by making clinical trial/GMP/approval experts join the research project from the R&D stage when providing assistance in obtaining product approval from product development and design stage
○ Experience and knowhow on effective operation and management of the life cycle process from product design to approval of a Convergence Medical Device, which is unusual and rare not like existing medical devices will bring a good opportunity to graft technologies from other industry onto medical device industry
(출처 : SUMMARY 5p)
과제명(ProjectTitle) : | - |
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연구책임자(Manager) : | - |
과제기간(DetailSeriesProject) : | - |
총연구비 (DetailSeriesProject) : | - |
키워드(keyword) : | - |
과제수행기간(LeadAgency) : | - |
연구목표(Goal) : | - |
연구내용(Abstract) : | - |
기대효과(Effect) : | - |
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