In May 2024, Illumax was awarded the ISO 13485 Medical Device Quality Management System Certificate by the German T ü V S ü D notified body.

Safety and quality are non-negotiable in the medical devices industry, that’s why ISO 13485developed.

Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.