We are excited to announce that we have been ISO 13485 certified!
ISO 13485 is an international standard for quality management system for medical devices.To become certified, we passed two stages of audits from the renowned certification body BSI.
Specifically, BSI certifies that we operate a Quality Management System which complies with the requirements of ISO 13485:2016 for the scope of “The design, development, sales and distribution of audiometer application for smartphone.” In other words, we are certified to develop medical device level hearing test apps for smartphones.
This is an important step towards our goal of making hearing care solutions more accessible.We will continue to follow international standards during our development to ensure that all medical devices we design are safe, reliable and effective.
