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.
ISO 9001:2008 Quality Management Systems - Requirements
ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
SOR/98-282 Canadian Medical Device Regulations (CMDR)
98/79/EC (IVD Directive), Annex IV: EC Certificate - Full Quality Assurance Certificate