DNA Diagnostic receives ISO 13485:2016 certification

Friday, May 25, 2018
DNA Diagnostic A/S announced today that the company has received ISO 13485:2016 certification from Presafe. This certification covers the company's quality management system that meet requirements specific to Production and Sale of Molecular Diagnostic kits, including eg. packaging, manufacturing and quality control. Certification covers the quality management system used to control production of our HemaVision products (CE-marked in vitro diagnostic devices for detection of leukemia translocations) as well as our diagnostic kits in the food and veterinary areas; eg. Mastit-4, Salmonella Velox, Pneumo 4 and Infant 3.
The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards quality management systems. The ISO 13485:2016 standard contains requirements for a comprehensive management system for the design and manufacture of medical devices including in vitro diagnostic devices.
“This certification testifies the level of quality control expected at DNA Diagnostic. With an expanding portfolio of products and customers, a high level of attention to detail is important to ensure that our products quality meet requirements.” Said Tina Mygind, Development & Production Manager for DNA Diagnostic A/S.
"Achieving 13485 certification demonstrates DNA Diagnostics ongoing commitment to an already robust quality system as well as our commitment to customers regarding our quality." said Mogens Sønderup, Chief Executive Officer for DNA Diagnostic A/S.


ISO 13485;2016 Certificate