Taahhüdümüz

LIJ Med Tube'da, 0,01 mm ölçülerindeki her mikrotüp yaşama saygıyı temsil eder. Tıbbi cihaz bileşenlerimizin son derece hassas ve güvenli olmasını sağlamak için ISO 13485 kalite yönetim sistemine sıkı sıkıya bağlıyız.

LIJ Med Tube - Quality Assurance

ISO 13485:2016 - Our Commitment to Medical Excellence

At LIJ Med Tube, ISO 13485:2016 is more than just a certificate; it's the soul of all our operations. As an international standard specifically developed for the medical device industry, it establishes our unwavering commitment to safety, effectiveness, and consistency in the field of precision microtube fabrication.

Each batch of raw materials (stainless steel, nickel-titanium, tungsten) must be checked for MTC (Material Test Certificate) before being put into storage. All raw materials comply with RoHS 3.0 and REACH environmental standards.

A high-resolution imaging measurement system (VMM) is used to ensure tolerances are controlled within 0.01 mm. A surface roughness tester is used to ensure the inner wall Ra value meets medical fluid transport requirements. A multi-stage ultrasonic cleaning process is employed, and residue detection is performed.

In HMLV (Multi-Specification Small Batch) production mode, we use SPC tools to monitor production stability and ensure the consistency of each batch of products.

Global Compliance Center

We are committed to a conflict-free supply chain. 100% of our minerals smelters are verified by RMI.

Supplier Code of Conduct

Updated on December 31, 2024

Conflict Minerals Policy

Updated on December 31, 2024

Annual Compliance Declaration

Under improvement

Rapid Changeover Validation

For customized microtubes, we have a mature FAI (First Article Inspection) process to ensure that even very small orders have the same quality standards as mass production.