Quality Assurance

Amplivox design, manufacture, supply and support products on a global basis to satisfy customer requirements and meet many regulatory requirements. It is therefore essential that we have rigorous and proactive quality assurance schemes in place to ensure that we achieve our quality management goals at all times.

ISO 13485:2016

Specifies the requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.