In February, we announced that we have been ISO 13485:2016-certified by BSI. Today, we are thrilled to share that we have passed this year’s surveillance audit and maintained our certification status.
As part of the certification scheme, BSI carries out continuing assessment visits - also known as surveillance audits - on an annual basis.
During the surveillance audits, BSI assesses whether we have continued to operate following an ISO 13485:2016-compliant Quality Management System for Medical Devices following the previous audit.
Besides the surveillance audit, the auditors also carried out a site relocation audit to ensure that our office relocation in January this year did not adversely impact our products or our quality management system.
The office address on our certificate is updated accordingly to display our new office address at Building 19W in Hong Kong Science Park.
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.We will continue to follow international standards during our development to ensure that all medical devices we design are safe, reliable and effective.