We are pleased to inform our customers that Omixon has successfully upgraded its ISO Certificate according to ISO 13485:2016 standard and migrated its EC Certificate from the BSI UK Notified Body (ID: 0086) to the BSI NL Notified Body (ID: 2797).
Our updated EC Certificate – Full Quality Assurance and ISO 13485:2016 Certificate can be found on Omixon website. Omixon is managing amendment of concerning documents (Instruction for Use, Declaration of Conformity) and notification of affected Competent Authorities. As manufacturers do not need to update labels immediately, migration-related changes on IVD product labels will be reflected in the coming 24 months.
Contact us if you have any questions!