This unique quality seal for reagents ensures performance and compliance of IVD components
With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine product performance and conformity under the requirements of the IVDR:
IVD manufacturers can obtain reagents developed and produced by myPOLS Biotec under ISO 13485 with an IVDR-compliant analytical performance (AP). The Johner Institute provides tested templates for AP and confirms with the DiagnosticGrade seal that the reagents meet the relevant requirements and thus ensure the maturity level for diagnostics.
This facilitates the development of new IVD products for IVD manufacturers and also enables the IVDR-compliant optimization of existing kits.
Please find more information on our detailed DiagnosticGrade-Service-Page (link) or contact us.