Built in compliance with GMP and ISO 14644-1 standards, with real-time monitoring of temperature, humidity, pressure differential, and particle levels to meet the manufacturing requirements of high-risk interventional devices.
Equipped with advanced testing instruments, including tensile testing machines, coating friction testers, torque testers, three-point bending testers, and optical measurement microscopes, enabling comprehensive evaluation of guidewire mechanical properties, coating performance, and dimensional accuracy.
Dedicated pilot production lines support rapid prototyping, process validation, and efficient transition from product design to mass production.