Omixon announce its Quality Management System complies with the requirements of ISO 13485:2003 certified by a CMDCAS recognised registrar. As a result Omixon’s QMS meets the Canadian Medical Devices Regulations for design, development, manufacture and distribution, servicing and customer support of In Vitro diagnostic reagents, kits and software for HLA tissue typing. Omixon can now start the registration procedure for its Next Generation Sequencing for HLA Genotyping products to enable offerings for diagnostic purposes in Canada.

We are looking forward to bringing our best-in-class assays and softwares to North-America!

Feel free to browse and download our CE & ISO certificates here…