CE-marked IVD products
For marketing in European countries, including Norway and Switzerland, all products intended for in vitro diagnostic use have to be CE marked. The CE mark shows that the products conform to the European Directive "98/79/EC In Vitro Diagnostic Medical Devices".
ISO-certification
Phadia GmbH, now Thermo Fisher Scientific, manufactures high quality diagnostic IVD products in full compliance with quality system standard ISO 13485:2003 and is regularly audited by its certification body DQS.
GMP (Good manufacturing practice)
For securing our high quality standards, Phadia, now Thermo Fisher Scientific, is manufacturing according to GMP/GLP guidelines.
Phadia's (now Thermo Fisher Scientific) quality management system has proven to be compliant with GMP requirements as demonstrated by successfully passed inspections.
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