SGS Medical Devices Laboratories: Taiwan

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).