SAALUX PHOTOTHERAPY

The device’s compliance with safety and quality standards has been verified by certificates recognized in three different geographies. In the European Union, TÜV SÜD’s Quality Management System Certificate under Annex IX of the EU MDR (Regulation (EU) 2017/745) and DIN EN ISO 13485 Quality Management System for Medical Devices certification demonstrate strict control of design, manufacturing and risk management processes. In Germany, the DGP GmbH §126 SGB V pre-qualification approval confirms the device’s acceptance in the statutory health insurance ecosystem as a supplier of “durable medical devices” and its compliance with procurement processes. In the US, FDA 510(k) Premarket Notification indicates that the equivalence assessment required for placing the device on the market has been successfully completed. Together, this certification package demonstrates that the product offers a high level of assurance in terms of clinical safety, regulatory compliance, traceability and compliance with reimbursement processes.