Manufacturing Quality

Dako's manufacturing facilities in Denmark and the USA have established quality management systems designed to live up to the most stringent standards in the in vitro diagnostics industry:

International standards:

ISO 9001:2008 Quality Management Systems - Requirements
ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

ISO 9001:2008 (DK)
ISO 13485:2003 (DK)
ISO 9001:2008 (US)
ISO 13485:2003 (US)

Canada:

SOR/98-282 Canadian Medical Device Regulations (CMDR)

ISO 13485:2003 CMDCAS (DK)
ISO 13485:2003 CMDCAS (US)

European Union:

98/79/EC (IVD Directive), Annex IV: EC Certificate - Full Quality Assurance Certificate

IVD - EC Certificate (DK)

IVD - EC Certificate (US)


The United States:

FDA 21CFR Part 820 Quality System Regulation

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Get in Touch with Dako in Austria

  • Pathology Products
    Dako Österreich GmbH

    info.at@dako.com
    +43 1 408 43 34 0
    +43 1 408 43 36

    Hietzinger Hauptstraβe 50/7
    A-1132 Wien

  • Flow Cytometry Products and Specific Proteins
    Szabo-Scandic HandelsgmbH & Co KG

    mail@szabo-scandic.com
    +43-1-489 3961-0
    +43-1-489 3961-7

    Quellenstraße 110
    1100 Wien

Detailed contact information

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