Incus Passes ISO 13485 Scope Extension Audit

ISO13485 certificate issued to Incus Company Limited by BSI

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 design, development, sales and distribution of audiometer application for smartphone.”


The new scope is:


“The design, development, sales and distribution of audiometer application for smartphone and television.”


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.

About Incus

Incus has redefined hearing devices by combining the power of traditional hearing aids with the convenience and accessibility of consumer electronics products.

Through continuous hearing technology innovation, Incus empowers people to stay connected with family, friends and the world.

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