Quality: ISO 13485 and ISO 9001 Certified

Our Cleanroom with Certificate

Quality: ISO 13485 and ISO 9001 Certified

At GTI Medical all medical projects are complying with ISO13485 & ISO 9001 standards.

GTI Medical provides the following QA Services:

  • Certificate of compliance, Certificate of Analysis and final inspection report are provided with each shipment (COC, COA & COT).
  • High precision measurement system using Four Axis Smart Scope OGP system.
  • Tensile testing and reporting.
  • Af temperature testing.
  • In house product packaging testing (dye/peel/burst).
  • In house Clean Room monitoring capabilities.
  • Custom packaging & labeling.

Quality Assurance (QA)

Our QA team assures the highest quality of manufactured products by implementing risk management methods to avoid setbacks in the delivering process to customers.

GTI’s QA team effectively engage in promoting quality assurance by improving process development and testing methods.

At GTI Medical our quality team oversee operations to ensure compliance with regulations while maintaining production costs, allowing us to provide our clients with the highest quality standards to ensure patient safety.