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 Italy

Contact Us Directly

info.it@dako.com
+39 02 58 078 1
+39 02 58 078 294

Pathology Products, Flow Cytometry Products and Specific Proteins
Dako Italia S.p.A.

Via Piero Gobetti, 2/C
IT-20063 Cernusco sul Naviglio (MI)

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