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).