Integrity Implants Inc.

(a) 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, except that Lauren Kamer is responsible for verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices. Lauren Kamer is also responsible for clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF.

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10) and d) the reporting obligations referred to in Articles 87 to 91 are fulfilled, except that Lauren Kamer is responsible for update of clinical evaluations including PMCF.

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date