NEOS SURGERY, S.L. is delighted to announce the obtained CE mark for STERN FIX under the new European Medical Device Regulation (MDR), complementing its existing 510(k) clearance in the United States. This milestone demonstrates our commitment to compliance with the latest regulatory standards and reaffirms our dedication to providing safe, effective, and innovative medical solutions to healthcare providers and patients across Europe.
Key Highlights:
- Compliance with MDR: The CE mark certification under the MDR validates that STERN FIX meets the stringent requirements outlined in the updated regulatory framework. This certification ensures that our product adheres to the highest standards of safety, quality, and performance.
- Enhanced Regulatory Approval: Building on its existing 510(k) clearance in the United States, the CE mark for STERN FIX underscores its global regulatory acceptance and validates its status as a trusted solution for sternotomy closure worldwide.
- Enhanced Safety and Efficacy: STERN FIX offers enhanced safety and efficacy in sternal stabilization, providing surgeons with a reliable solution for sternotomy closure and improving patient outcomes. With its advanced design and materials, STERN FIX sets a new standard for sternal fixation in Europe.
- Benefits for Healthcare Providers and Patients: The CE mark certification enables healthcare providers and patients to access STERN FIX with confidence, knowing that it complies with the latest regulatory requirements and delivers superior performance in cardiac surgery procedures.
“We are thrilled to receive the CE mark for STERN FIX, marking a significant achievement in our journey to provide innovative solutions for cardiac surgery. This certification underscores our commitment to compliance with the latest regulatory standards and our dedication to advancing patient care. We look forward to continuing to make a positive impact on healthcare with STERN FIX.” – Lluís Chico, CEO, NEO SURGERY, S.L.
