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CRDMO Service

Advanced Medical Device Development

Global level one-stop service for advanced medical device development

Goals

첨단의료기기개발지원 센터의 목표입니다. 자세한 내용은 아래 글을 참고해 주세요.

맨 왼쪽 부터 시계방향으로 진행됩니다.

Support for BT-based medical device joint research and development
  • Intensive support for implantable level 3 and 4 medical devices
  • Joint research and development tailored to consumers
  • Generic technology building joint R&D
Technical support for commercialization using infrastructure
  • Prototype production for commercialization
  • Technical support using equipment and facilities
  • Inspection of prototype safety, performance, biocompatibility, and electromagnetic testing
Industry demand survey
  • Medical device market and technology trends
  • Status of medical device IP
  • Medical device cluster policy trends
Building internal and external cooperation network
  • Establishing a cooperation system with domestic and overseas medical device related agencies
  • Hosting symposiums and conferences
  • Training specialists for the development of advanced medical devices

KBIO HEALTH 첨단의료기기개발지원센터

Support for BT-based medical device joint research and development
  • Intensive support for implantable level 3 and 4 medical devices
  • Joint research and development tailored to consumers
  • Generic technology building joint R&D
Technical support for commercialization using infrastructure
  • Prototype production for commercialization
  • Technical support using equipment and facilities
  • Inspection of prototype safety, performance, biocompatibility, and electromagnetic testing
Industry demand survey
  • Medical device market and technology trends
  • Status of medical device IP
  • Medical device cluster policy trends
Building internal and external cooperation network
  • Establishing a cooperation system with domestic and overseas medical device related agencies
  • Hosting symposiums and conferences
  • Training specialists for the development of advanced medical devices

Direction of support

첨단의료기기개발센터의 지원방향 설명입니다. Joint R&D, Design prototyping, Testing, inspection, and evaluation
Joint R&D Design prototyping Testing, inspection, and evaluation
Technical support
  • Conduct joint research utilizing future leading core technology and consumer tailored joint technology infrastructure.
Prototype production support using facility and equipment
  • Medical device design and analysis
  • Support for molding production using 3D printer
  • Medical device ultra-precision processing and measurement
  • Precision machining of major parts for medical devices
  • Licensing and approval test for nine product groups of the Ministry of Food and Drug Safety
  • Support for evaluating the issuance of KOLAS
첨단의료기기개발센터의 지원방향 설명입니다. Joint R&D, Design prototyping, Testing, inspection, and evaluation
Joint R&D
Technical support
  • Conduct joint research utilizing future leading core technology and consumer tailored joint technology infrastructure.
Design prototyping
Prototype production support using facility and equipment
  • Medical device design and analysis
  • Support for molding production using 3D printer
  • Medical device ultra-precision processing and measurement
  • Precision machining of major parts for medical devices
Testing, inspection, and evaluation
  • Licensing and approval test for nine product groups of the Ministry of Food and Drug Safety
  • Support for evaluating the issuance of KOLAS
첨단의료기기개발센터의 기기입니다.
Development of biomolecular imaging/treatment system general prototyping electric/mechanical safety evaluation
biomaterial implant development rapid prototyping production biological safety evaluation
preclinical evaluation
high-clean manufacturing for implantable medical devices ultra-precision processing and measurement electromagnetic performance evaluation
Development of biomolecular imaging/treatment system
general prototyping
electric/mechanical safety evaluation
biomaterial implant development
rapid prototyping production
biological safety evaluation
high-clean manufacturing for implantable medical devices
ultra-precision processing and measurement
preclinical evaluation
electromagnetic performance evaluation

Main Role

Support for implantation / convergence medical device development
  • Human body insertion/graft type packaging technology
  • Metal low temperature fusion technology
  • Implantable lead/electrode fabrication
  • Digital circuit design
  • Micro and low power circuit design and fabrication
  • Wireless power communication, RF design
  • Feedback control
  • DAQ and animal testing
  • Convergence medical device and system development
R&D of laser optical convergence diagnosis and treatment system
  • Support for the development of biomolecular imaging system (HW/SW) for cancer diagnosis and treatment
  • Support for optical image diagnosis/treatment system (HW/SW) development
  • Support for the development of a system (HW/SW) for the production of micro scanning probe
  • Support for the development of a system (H /SW) for manufacturing invasive optical sensor
  • Support for the development of a system (HW/SW) for high speed/large capacity image data processing
  • Support for the development of human implantable micro optical lens and module
  • Support for the development of image quality evaluation and image correction system (HW/SW)
  • Support for the development of production process and inspection system to improve the productivity of medical device products
Orthopedic Implant R&D Support
  • Construction of an orthopedic implant development system
  • Orthopedic implant design and analysis
  • Orthopedics prototype development/Biomechanical analysis
  • Orthopedic implant development and commercialization support
Micro/Nano technology convergence precision diagnosis / Treatment system R&D support
  • R&D of high sensitivity bio-sensing technology
  • Research on the development of microfluidic device and lab-on-a-chip technology
  • Research on the development of high sensitivity multichannel fluorescence detection technology
  • Research on the development of medical micro sensor/actuator
  • Research on the development of surface treatment and bio-conjugation technology
  • Research on fluid and instrument analysis
Support for ultra-precision machining and measurement
  • Prototyping of medical devices using ultra-precision & polishing machines
  • Development of measuring and analysis techniques for ultra-precision medical device prototypes
  • Surface enhancement of prototypes using DLC coating and glass lens molding
Customized service ranging from design and analysis to prototyping of medical devices
  • Support for prototyping of medical devices
  • Establishment of standard operation procedure for manufacturing process
  • 3D Printing application techniques
  • Manufacture of tools for evaluation of medical devices
Support for 3D design and analysis of medical devices
  • Structure and system design
  • Reverse engineering
  • Computational structure and flow analysis
R&D of laser optical convergence diagnosis and treatment system
  • Support for domestic and overseas test inspection and debugging for commercialization of medical device products
    • Support for ISO 10993 Series and biological safety tests notified by the Ministry of Drug and Food Safety
    • Support for performance evaluation of medical supplies such as stents
    • Support for MRI conformity safety assessment
  • Support for the specialization performance test of the product group designated by the center
    • Support for specification test and manufacturer-specified performance test on medical supplies such as ASTM and ISO
    • Support for the test guide for the performance test of specialization product group
Support for the evaluation of medical device electromagnetic wave
  • EMC specialized research of medical devices through electromagnetic wave evaluation and analysis of electrical/electronic medical devices
  • Support for countermeasure design and debugging based on certification evaluation
  • Providing EMC total solutions for medical devices by supporting certification evaluation debugging from the design stage considering EMC

Application for Support

  • Emailcephas@kbiohealth.kr
  • Senior Researcherkwon kiwon
  • Phone+82-43-200-9654