Allergan Sales, LLC

Ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. In the case of investigational devices, ensuring that a signed statement is issued, stating that the device conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation, and that every precaution has been taken to protect the health and safety of the subject.

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. Ensuring the post-market surveillance obligations are complied with in accordance with applicable regulations. Ensuring the reporting obligations are fulfilled in accordance with applicable regulations.

Ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. In the case of investigational devices, ensuring that a signed statement is issued, stating that the device conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation, and that every precaution has been taken to protect the health and safety of the subject.

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. Ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. Ensuring the post-market surveillance obligations are complied with in accordance with applicable regulations. Ensuring the reporting obligations are fulfilled in accordance with applicable regulations.