ISO 13485 Certification

APrevent announced today that it has been assessed by DQS Holding GmbH (DQS) and recommended for ISO 13485 certification for its Vocal Implant System (VOIS), a flexible implant system for arytenoid adduction, DQS, an independent certifying agency, concluded that the company complies with the requirements of ISO 13485 for an integrated quality management system for medical devices across design, manufacture and sales.
 
The ISO 13485 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices. With this certification, APrevent will be proceeding with a CE Mark application in Europe.