Raising the Bar on Medical Device QC
Quality assurance is the highest priority for medical device manufacturers. X-ray inspection can play a critical role in ensuring that only the first quality product reaches consumers. Whether the inspection is done manually, autonomously, or a combination of the two, validation with X-ray can be the difference between catching and correcting manufacturing errors in-house, or having them result in a recall.
One of our recent custom systems was designed to eliminate incidents of spring placement errors within a medical device sub-assembly. The springs are critical to the function of the device, and mistakes in their placement could cause harm or even death to patients relying on this device. This custom system, built on our TruView™ Prime platform, was crafted specifically to identify missing, damaged, or nested springs. The sub-assemblies are inspected and validated prior to moving on through the assembly line. Two operators view X-ray images, acquired in mere seconds, from separate screens. The product passed by both operators exits the system and continues down the assembly line. When there is disagreement, or a product is failed by both operators, the product remains quarantined within the system for disposition by a supervisor. This simple, rapid, integrated inspection, prevents errors that once resulted in a 100% product recall.
When integrated into a manufacturing line, X-ray inspection can validate sub-assemblies, completed assemblies, and even packaged goods. Inspection can be tailored to meet the demands of all types of medical devices including electromechanical, implantable, autoinjectors, catheters, surgical kits, and more. Toolboxes are available to support manual, automated, and even autonomous inspection options.