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The Finnish Competent Authority Valvira has on 13th August 2013 designated SGS Fimko Ltd as a Notified Body for Medical Devices. The designation is partly based on accreditation carried out by FINAS Accreditation Services in July. The designation and the scope will be updated to the European database Nando. SGS Fimko Ltd carries the Notified Body identification number 0598.

SGS Fimko Ltd offers also Quality Systems certification services. In addition to ISO 13485 certificates for medical device manufacturers, we can provide certification to other quality system standards, such as ISO 9001 and ISO 14001.

In our role as a Notified Body, quality system certifier and CB testing laboratory we can take advantage of the global network of SGS’s offices and testing laboratories. In this framework we can provide medical device companies access not only to Europe, but also to other key markets, such as Canada, Japan, China, Taiwan, Russia and Brazil.

"SGS aims to provide medical device manufacturers a comprehensive range of services as a ticket to the international markets. Medical devices play an important role within the high-tech industry and we forecast that the sector will continue to grow profitably. As a customer for SGS, the medical device industry can remarkably simplify their efforts related to authorization processes”, says Product Manager Seppo Vahasalo.

ADDITIONAL INFORMATION:

  • Seppo Vahasalo, m.  +358 40 560 9500.