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 Netherlands

Contact Us Directly

info.nl@dako.com
+31 20 42 11 100
+31 20 42 11 101

Pathology Products, Flow Cytometry Products and Specific Proteins
Dako Netherlands bv

p/a Interleuvenlaan 12B
B-3001 Heverlee
Belgium

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