Automation & Testing

A mid-sized medical device electronics manufacturer required documented evidence of proper installation, intended operation, and compliance with 21 CFR Part 820 and ISO 13485:2016 for a newly installed Medalist i3070 In-Circuit Test (ICT) system supporting Class II medical devices. Key challenges included validating complex hardware and software configurations, ensuring electronic data integrity, controlling system access, and demonstrating compliance with FDA and ISO requirements.

Cooper Surgical required a validated automated test system for Lumax S-Series fiber optic extension cables used in surgical catheter applications. The challenge involved designing and qualifying a custom test system that could perform comprehensive optical and pneumatic testing without requiring external optical measurement equipment or reference standards. Critical concerns included ensuring accurate optical throughput measurements for fiber optic cables, detecting optical crosstalk between fiber channels, measuring pneumatic leakage and flow rate within tight tolerances, detecting pneumatic obstructions in cable pathways, integrating with existing Lumax Catheter ATE database via Ethernet, achieving self-calibration capability without external equipment, and providing an operator-friendly touchscreen interface for production environments.

A medical device manufacturer required documented evidence that the Agilent Medalist i3070 In-Circuit Test (ICT) system was properly installed, calibrated, and operating according to design specifications. The challenge involved validating a complex automated test platform incorporating hardware, software, and electrical safety testing capabilities while ensuring compliance with medical device quality system requirements and maintaining data integrity for production use.