AUG Medical LLC

1. Drawing up and keeping up to date of the technical documentation and the EU declaration of conformity of registered medical devices with EU Competent Authority. 2. Fulfillment of the post-market surveillance obligations in accordance with Article 10(10) of MDR. 3. Reporting obligations referred to in Articles 87 to 91 whereas needed. 4. Quality management system Regulatory Guidelines 5. Represent AUG Medical LLC on regulatory platforms and communication with stakeholder authorities.