Stress EEG Assessment System passed the TFDA QMS audit and received a manufacturing license

The Stress EEG Assessment (SEA) System passed the TFDA QMS audit in June 2022, becoming one of the first domestically produced software asmedical devices (SaMD) to obtain a QMS manufacturing license, and was registered in the domestic QMS/GMP manufacturing license dataset (number QMS2055).

QMS/GMP manufacturing license dataset：

https://www.fda.gov.tw/tc/sitecontent.aspx?sid=2318