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Medical Device Lab

Introducing SGS Finland Lab

SGS Fimko’s Medical Devices testing laboratories in Helsinki and Tampere employ medical device experts that together have more than twenty years of experience in standardization, regulatory requirements, testing and compliance to international medical device standards.

  • Established: 2012 (Helsinki), 2013 (Tampere)
  • Employees: 12

Key Competences for Electro Medical Devices

  • Patient monitoring equipment
  • Dental equipment (e.g. x-ray systems)
  • Mammography systems
  • Hospital beds and operating tables
  • MRI
  • Electromagnetic Compatibility (EMC), Product Safety
  • Wireless Testing/Telemedicine Battery Testing
  • Restricted Substances Testing (including RoHS requirements)
  • KFDA Certification
  • Packing Testing

SGS Finland Features

The Finland labs serve as the gateway for services in Finland for Electro Medical Devices. Accreditations and approvals received by this two facilities include:

  • DIN EN ISO 13485:2003 by SGS Fimko 
  • ISO 9001:2008 in combination with ISO 13485:2003

A dedicated project engineer located close to you, will help to handle all your testing, certification and other service needs. Furthermore, we will support you by pre-testing and training in complex regulatory compliance issues, such as risk management requirements.

  • Medical Device Directive 93/42/EC
  • Medical Device CE marking for the EU 
  • REACH. RoHS, Good Distribution Practice, BRC Consumer Products Certification, etc.

The Finish SGS labs will complete your testing to comply with relevant standards and your specific requirements by offering a wide range of marks to help you gain access to the global marketplace.

  • Europe (CE, EN Standards)
  • CB (Global, IEC Standards)
  • Canada (CSA Standards)
  • USA (NRTL, FCC)
  • Canada (CMDCAS)
  • Japan (JPAL)
  • Brazil (INMETRO)
  • Russia (EAC)
  • China (CFDA) 
  • Third party certifications for Taiwan, Australia and Hong Kong

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 FIMKO Oy
P.O. Box 128
Särkiniementie 3
Helsinki, FI-00211
Finland
t: +358 40 560 9500