we understand that medical products must meet the highest safety and quality standards to be trusted in hospitals, clinics, and healthcare facilities worldwide. That’s why we have obtained multiple internationally recognized certifications to guarantee our products meet strict regulatory requirements.
- CE Certification (Conformité Européenne)
- ISO 13485 Quality Management System
- FDA Registration (U.S. Food and Drug Administration)
Our products carry the CE mark, demonstrating compliance with EU safety, health, and environmental protection standards. This ensures smooth market access across Europe and builds confidence among healthcare providers and distributors.
We operate under ISO 13485, a globally recognized standard for medical device quality management. This certification reflects our commitment to consistent manufacturing processes, risk management, and continuous improvement, ensuring product safety and reliability at every stage.
Selected products are registered with the FDA, meeting U.S. regulatory requirements for medical devices. This confirms that our products adhere to rigorous standards for safety, efficacy, and traceability, making them suitable for one of the world’s most demanding markets.
Beyond Certifications
Our dedication goes beyond simply holding certifications. We have implemented a comprehensive quality assurance system, including:
- Raw material inspection and supplier qualification
- In-process quality control and batch testing
- Final inspection before shipment
- Traceability and post-market surveillance
Your Assurance, Our Responsibility
By partnering with us, you gain access to products that not only meet international standards but also reflect our commitment to safeguarding patients and supporting healthcare professionals worldwide.