Compliance Statement

This document confirms adherence to the Medical Device Regulation (MDR) EU 2017/745, which governs the safety and performance requirements for medical devices within the European Union.

Key Points:

• Regulation Reference: EU 2017/745 (MDR)
• Compliance: The product or process described meets the mandatory requirements set forth by the MDR.
• Scope: Ensures conformity with EU standards for medical devices, including safety, efficacy, and quality controls.