Cook Biotech Incorporated

Management of Regulatory Documentation Technical Documentation: The full set of documentation that demonstrates the device's compliance with the MDR's safety and performance requirements. EU Declaration of Conformity: The official declaration by the manufacturer that the device complies with the regulation.

Verification of Device Conformity 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

Post Market Surveillance (PMS) Oversight Ensuring the post-market surveillance obligations for the manufacturer are complied with in accordance with Article 10(10) of the EU MDR Vigilance and Reporting Obligations Ensuring all the reporting obligations for the manufacturer referred to in Articles 87 to 91 of the EU MDR are fulfilled