COMPANY

Organization

CEO

Management
Support Team

  • Advisory committee

  • Global Support Team

  • Legal Support Team

MFDS
Approval Team
  • Medical device approval
    (electric, machine, supplies)
  • in-vitro diagnosis medical device approval
  • Quasi drugs approval
  • Functional cosmetics approval
  • KGMP(Domestic/overseas)
  • IEC 60601 3rd test
  • Medical device for animal
  • Clinical trial(CRO)
Overseas Certification Team
  • CE / MDR
  • ISO 13485
  • FDA CDRH
  • MHLW
  • CFDA
  • ROHS
  • MDSAP
  • PMDA
Marketing Team
  • Manufacture process development
  • Medical device research and development
  • Manufacture process optimization
  • ICC/OMS(License holder service)
  • Business of nation research and development
  • Insurance registration(reimbursement registration)
  • New health technology assessment