Certifications & Compliance
At Trumex Instruments, regulatory compliance and international quality standards are integral to our mission. We are actively preparing to meet and maintain globally recognized certifications as we grow.
➤ ISO 9001: Quality Management System
We are in the process of acquiring ISO 9001 certification — the global standard for Quality Management Systems (QMS). This ensures our manufacturing process is efficient, consistent, and customer-focused.
➤ ISO 13485: Medical Device Compliance
To meet the requirements of medical markets, we are also working toward ISO 13485 certification. This standard ensures the safety, traceability, and reliability of our micro surgical instruments.
➤ CE Marking: European Union Compliance
Our instruments will soon carry the CE mark, confirming compliance with essential EU directives regarding safety, performance, and environmental protection.
➤ FDA Clearance (Coming Soon)
We are committed to achieving FDA clearance for the U.S. market in the near future. While this is a long-term process, we are already aligning our production and documentation standards with FDA guidelines.
For more information, or to request specific compliance details, feel free to contact us directly.