WS Audiology is ‘First Hearing Aid Company’ to Receive Eu MDR Certification

The certification process at WS Audiology, with hearing aids and related software in scope, started with on-site audits in October and November of 11 sites in Europe, the US, China, and Singapore. During these audits, the company reports that its new quality management system was reviewed by notified body TüV Süd to ensure compliance to the EU Medical Device Regulation.