At ATRON HEALTH SA, we are committed to trading and distributing medical devices and implants that have the quality and safety needed to satisfy our customers and users of our products and to comply with applicable standards, regulations and requirements.
By implementing an ISO 9001: 2015 Quality Management System, we strive to comply with applicable requirements, effective maintenance and continuous improvement of the System.
By applying specific Protocols, we meet the requirements of the Presidential Decree No. 129 on the Adaptation into national law of the Commission EU Directive 2015/565 of 8 April 2015 amending Directive 2006/86/EC (OJ L 93 / 9.4.2015, p. 43 et seq.) and Commission Directive 2015/566 of 8 April 2015 Implementing Directive 2004/23/EC (OJ L 93 / 9.4.2015, p. 56 et seq.).
The senior management of ATRON HEALTH SA thus provides all the necessary resources and acts to ensure that its products are safe at every stage, from the manufacturer’s design, and that their performance safely meets customer requirements.
The staff of ATRON HEALTH SA is kept informed about the Quality Policy and the documentation and requirements of the QMS and is capable and appropriately trained in all tasks and operations that affect product quality and safety. The Quality Policy is reviewed annually by the Management of ATRON HEALTH SA, which determines, controls and approves quality objectives, providing documented and objective data on the compliance and performance of the Services and the System.