Golden Helix Inc.

Technical documentation and EU declaration of conformity are maintained at Golden Helix, Inc. Post-market surveillance obligations are met, including: supplier/sub-contractor management; reporting of serious incidents and field safety corrective actions to competent authority/notified body; reporting statistically significant increases in incident frequency/severity; and investigation of serious incidents entered as field safety notices in EUDAMED. Section 4.1 Annex XIV IVDR statement is issued.

Ensuring the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.