As AENDUO S.r.l. operates as a manufacturer of medical devices pursuant to Directive 93/42/EEC, as amended and supplemented, and Regulation (EU) 2017/745, the Company is particularly attentive to market needs and considers feedback information to be of fundamental importance through the adoption of an appropriate Quality Assurance and Quality Control policy in compliance with ISO 9001, ISO 27001 and ISO 13485 standards.

In particular, Management has established the following objectives:

• to comply with the requirements set forth in Legislative Decree No. 46 of 24 February 1997, as amended and supplemented, and in Regulation (EU) 2017/745;
• to comply with all applicable and current mandatory regulations, particularly those relating to worker safety and the safety of medical devices, Common Specifications and MDCG (Medical Device Coordination Group) guidance;
• to ensure product functionality and continuous improvement;
• to obtain and maintain certification of the Quality Management System in accordance with ISO 9001:2015, ISO 27001 and ISO 13485;
• to ensure the quality and safety of marketed products;
• to prevent defects rather than eliminate them after they have occurred;
• to ensure responsibility and accountability for one's own work;
• to maintain a strong commitment to fulfilling applicable requirements and maintaining the effectiveness of the Quality Management System;
• to implement the improvements necessary to maintain the effectiveness of the Quality Management System and its processes;
• to evaluate customer feedback regarding the products/services provided;
• to periodically assess new customer needs;
• to periodically assess risks and opportunities for improvement relating to company processes;
• to plan changes and continuously verify the integrity of the system;
• to ensure information security through the continuous provision of essential support for the Company's Core Business, using the most advanced technological means and tools and maintaining them in a state of full operational efficiency; through the periodic and systematic analysis and identification of threats to the information managed, assessing actual exposure to risks and implementing appropriate countermeasures to eliminate or mitigate their effects.

To achieve these objectives, the Company is committed to continuously conducting market research aimed at updating and improving its products, together with a careful evaluation and selection of suppliers.

This policy will make a decisive contribution to ensuring the reliability, professionalism and efficiency that have always characterized the Company's activities. To this end, Management and the QA function are committed to supporting all personnel in correctly implementing the Quality Management System procedures, providing appropriate training and encouraging them to pursue the required level of quality improvement.