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

Country selection

Your Dako Account indicates that you are based in , you will be transfered to the web site for

Basket emptied

Your basket was emptied because of the country change.

Country selection

United States of America appears to be your location. To view country specific information on the Dako web site, please accept or change country below.



Get in Touch with Dako in Myanmar

Contact Us Directly

sales@spdscientific.com.sg
+65 6303 9877
+65 6775 0995

Pathology Products, Flow Cytometry Products and Specific Proteins
Please inquire at
SPD Scientific Pte Ltd

Blk 192, Pandan Loop #06-20
Pantech Business Hub
Singapore 128381
Singapore

Detailed contact information

Submit an Inquiry

How would you like us to follow up?


Cancel