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SGS Taiwan provides a professional one-stop testing and certification service for EE medical devices.

Established in 1996, SGS Taiwan currently employs over 2,700 highly-trained staff, providing a professional one-stop testing and certification service for electronical and electronic (EE) medical devices.

Our EE medical laboratory supplies accredited certification services against standards bodies in both national and international markets – including: IECEE (IEC System of Conformity Assessment Schemes for Electronical Equipment and Components); ILAC (International Laboratory Accreditation Cooperation); and TAF (Taiwan Accreditation Foundation).
 
With extensive experience in the EE medical device sector, SGS Taiwan can assist with a wide range of regulatory compliance, including:
  • ISO 13485
  • CE MDD 93/42/EEC
  • CE IVD 98/79/EC
  • JPAL (Japan)
  • Inmetro (Brazil)
  • CMDCAS (Canada)

In addition to regulatory compliance, SGS Taiwan also offers testing and certification against:

  • IEC 60601-1 – safety
  • IEC 60601-2-XX – performance
  • IEC 60601-1-2 – EMC
  • IEC 60601-1-1-6 & IEC 62366 – usability
  • IEC 62304 – software
  • IEC 62471, 60825-1 – LED & laser
  • ISO 10993 series – biocompatibility
  • RoHS & REACH
  • Mechanical testing against medical device standards
  • Reliability testing

Finally, SGS Taiwan is fully qualified to conduct factory inspections to demonstrate compliance with certification schemes in North America (SGS Q Mark) and Brazil (Inmetro).