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 9001:2000 Quality Management Systems - Requirements

ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

Canada:
SOR/98-282 Canadian Medical Device Regulations (CMDR)

European Union:
98/79/EC (IVD Directive), Annex IV: EC Certificate - Full Quality Assurance Certificate

United States:
FDA 21CFR Part 820 Quality System Regulation