In February 2020 we announced that we had been ISO 13485-certified by BSI.
Since then, we have developed new technologies and solutions to achieve our mission of using sound and technology to keep people connected.
BSI carried out a scope extension audit to assess whether our updated quality management system for medical devices is suitable for the new scope.
The old scope was:
The new scope is:
Through this scope extension audit, we have demonstrated our capability to provide audiometer applications for television.
BSI certifies that we operate a Quality Management System which complies with the requirements of ISO 13485:2016 for the new scope.
We will continue to follow international standards during our development to ensure that all medical devices we design are safe, reliable and effective.