Echo-Son S.A. obtains ISO 13485 and CE MDR certification
We are pleased to announce that Echo-Son S.A. has obtained certification of its quality management system in accordance with ISO 13485:2016, as well as certification under Regulation (EU) 2017/745 on medical devices — MDR.
The certificates were issued by the notified body CE Certiso Kft., identification number 2409.
The certification confirms that our medical device design, manufacturing, servicing and sales processes are carried out in accordance with the applicable European quality and regulatory requirements.
The successful completion of the MDR certification process represents an important milestone in the continued development of Echo-Son S.A. and confirms our commitment to ensuring the safety, quality, performance and reliability of our ultrasound solutions.
The certificates also provide a strong foundation for the further development of our product portfolio and for continued cooperation with our partners in domestic and international markets.
The current certificates are available on the Echo-Son S.A. website in the Certificates section.