GTI Medical Quality Assurance

ISO 13485 and ISO 9001 certified

Quality Assurance (QA)

GTI Medical’s QA team ensures the highest quality of manufactured products by implementing risk management methods to prevent delays in customer deliveries.

GTI’s QA team improves process development and testing methods to strengthen quality outcomes.
At GTI, our quality team oversees operations to ensure compliance with regulations while controlling production costs, enabling us to deliver the highest quality standards and ensure patient safety.

CERTIFICATES

At GTI, all medical projects comply with ISO 13485 and ISO 9001 standards.
FDA Owner Operator Number 10089718

QA services

GTI provides the following QA services
tensile
Tensile testing and reporting
precision
High-precision measurement system using a four-axis OGP SmartScope
certificate
Certificate of compliance, certificate of analysis, and final inspection report are provided with each shipment (COC, COA, & COT)
temperature
Af temperature testing
in house
In-house product packaging testing (Dye/Peel/Burst)
clean room
In-house clean room monitoring capabilities
custom
Custom packaging and labeling
Metallurgical Cross Section of Laser welding Icon
Metallurgical cross-section of laser welding

contact us

    info@gti-medical.com
    09-7667772

    29 Yad Harutzim Street, Building 6, 1st Floor
    Poleg Industrial Zone
    Netanya 4250529
    Israel

    GTI Medical is a global provider of advanced microfabrication and precision laser solutions for the medical, defense and aerospace industries.
    We specialize in precision laser cutting, laser welding, nitinol machining, electropolishing, passivation and cleanroom assembly, providing high-performance manufacturing to ISO 13485 and ISO 9001 standards—from prototype to full-scale production.