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)


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Get in Touch with Dako in Sweden

  • Pathology Products and Specific Proteins
    Dako Sweden AB

    info.se@dako.com
    +46 8 556 20 600
    +46 8 556 20 619

    Box 1449
    S-114 79 Stockholm

  • Flow Cytometry Products and Specific Proteins
    Electra-Box Diagnostica AB

    info@electrabox.com
    +46 08-4487370
    +46 08-7126509

    Box 2035, 135 02 Tyresö
    Solkraftsvägen 18B, 13570 Stockholm

Detailed contact information

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