Reliable device performance is critical for both patient safety and regulatory compliance. At 2RA Labs, we specialize in performance and robustness testing for Pen injectors, Autoinjectors, Pre-fillied Syringes and on-body delivery systems (OBDS). Our testing programs are built around ISO 11608 series standards and are designed to support global regulatory submissions, ensuring your devices consistently perform under real-world conditions.
Device Performance Testing evaluates how a medical device performs under expected usage conditions. It verifies the mechanical, functional, and operational characteristics of the device to ensure reliability, precision, and consistency throughout its lifecycle.
Performance testing ensures that pen injectors, auto-injectors, and similar devices deliver medication accurately and consistently. It helps confirm dose accuracy, activation force, injection time, and overall user safety essential for patient trust and regulatory compliance.
Common parameters include actuation force, needle insertion depth, injection speed, dose volume accuracy, device robustness, and temperature/humidity tolerance. These are analyzed using precision instruments and high-speed data capture systems.
Our testing aligns with ISO 11608, ISO 23908, ISO 17025, ISO 11040 and other relevant international standards for medical device performance and safety. Compliance with these ensures global market readiness and regulatory approval.
We perform environmental conditioning, mechanical stress analysis, and functional tests under controlled temperature, humidity, and load conditions to mimic actual usage scenarios and patient handling.
Yes, 2RA Labs specializes in custom test setups for novel or non-standard devices. We design fixtures, develop testing protocols, and integrate sensors and software to meet unique performance assessment requirements.
