Milestone ISO 13485 Certification for hearX group

After two years of hard work in making sure our hearing health technology complies with international standards, hearX Group is proud to announce that we are now ISO 13485 certified.

ISO 13485 is the international standard for quality management systems of medical devices.

To become ISO certified, hearX Group has gone through an external evaluation process by Lloyd’s Register Quality Assurance. This included a pre-audit, a management system documentation review, quality management system development, initial assessment, and clearance of non-conformances, to ensure that we comply with world-class medical device specifications whilst meeting our customers’ needs. Our ISO accreditation demonstrates our commitment to provide products and services that are safe, reliable and of good quality to our existing and future customers.

To maintain our certification, hearX Group needs to demonstrate its ability to constantly provide products and services that meet customer requirements and international standards through the effective application of the system and with continuous product and service improvements. This certification further strengthens our commitment to our vision of bringing healthy hearing to everyone everywhere!

hearX Group would like to make use of this opportunity to thank our partners and customers for their commitment and continued support.