INDUSTRIES

Medical Device

Since medical device are directly connected to our life, international standards are applied more strictly than the standards of other products. It is important to have an accurate understanding and preparation of individual market regulations, as different standards of each countries apply to products. We provide accurate and prompt certification support with appropriate standards-based testing and professional technical advice.
Test Scope (All product group)
  • Electromagnetic Immunity
    • IEC 61000-4-2
    • IEC 61000-4-3
    • IEC 61000-4-4
    • IEC 61000-4-4
    • IEC 61000-4-6
    • IEC 61000-4-8
    • IEC 61000-4-11 + AMD1
  • Electromagnetic Emissions
    • IEC/CISPR 11
    • IEC/CISPR 14-1
    • CISPR 32
    • IEC 61000-3-2
    • IEC 61000-3-3 + AMD1
  • Product Safety
    • General standard : IEC 60601-1 + AMD1
    • Collateral standard : IEC 60601-1-x ( x : 2, 6, 8 )
    • Particular : IEC 60601-2-xx ( xx : 5, 10, 22 ),
      IEC 80601-2-xx ( xx : 30, 60 )
    • S/W Validation : IEC 62366-1
    • Usability : IEC 62304 + AMD1
Main Support Certification
  • Medical Device
    • MFDS(Rep. of Korea) : TCF, RM, Usability, S/W Validation, KGMP
    • CE(Europe) : 93/42/EEC(MDD), 2017/745(MDR)
    • FDA & OHSA(U.S.A) : 21 CFR Act, NRTL
    • Health Canada(Canada) : MDL, MDEL
  • Quasi-Drugs Mask
    • MFDS(Rep. of Korea): Surgical(Dental)(3210), KF94/KF80(3220), Saliva droplet prevention(3230)
    • CE(Europe) : Surgical_MDD/MDR, Respirator_PPER
    • FDA&NIOSH(U.S.A) : Surgical, N95 Respirator(42 CFR Part 84)