SGS Taiwan was established in 1992 and provides professional one-stop testing and certification services for electrical and electronic (EE) medical devices.

Introducing SGS Taiwan Lab

SGS Taiwan provides professional one-stop testing and certification services for electrical and electronic (EE) medical devices. Services include:

 

  • Regulatory Compliance Services
  • Testing services

Established: 1996

Employees: more than 2,700

Laboratory Features

Accreditations

SGS Taiwan’s EE medical devices lab helps speed products’ route to market and is accredited to both national and international certification schemes and standards bodies, including:

  • IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components)
  • ILAC (International Laboratory Accreditation Cooperation)
  • TAF (Taiwan Accreditation Foundation)

Key Services for One-Stop Medical Device Certification

With extensive experience in the EE medical devices sector, SGS Taiwan offers testing against all relevant standards, including:

Regulatory compliance:

  • ISO 13485
  • CE MDD 93/42/EEC
  • CE IVD 98/79/EC
  • JPAL(Japan)
  • Inmetro (Brazil)
  • CMDCAS (Canada)

Testing & certification against:

  • IEC 60601-1 – safety
  • IEC 60601-2-XX – performance
  • IEC 60601-1-2 – EMC
  • IEC 60601-1-6 & 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

Factory Inspections

We are qualified to conduct factory inspections to demonstrate compliance with certification schemes including:

  • North American USA & Canada (SGS Q mark)
  • Brazil (Inmetro)

 

Do you want to keep up to date with the latest EE and Medical Devices news, views and issues?  Join our LinkedIn community and be part of the conversation.

For further information, please contact:

SGS Taiwan Limited
No. 134, Wu Kung Road
New Taipei Industrial Park
New Taipei City, 24803
Taiwan
t: +88 2 2299 3279
f: +88 2 2299 3259
www.sgs.com.tw