Secure and verifiable data archiving, for years the standard in aerospace inspection, is now under increasing demand for medical devices.
Medical device manufacturers face a number of inspection challenges – some common to all precision manufacturers, others unique to their industry. Among these challenges are evolving design parameters and manufacturing methods, a deficiency in legacy part knowledge, and ever-stricter archiving standards imposed by many national regulatory agencies.
The truth is that today’s manufacturers should be archiving all inspection data. Equally true is that design changes in the medical device industry remain too slow and far too expensive. Faster innovation, faster product development, and faster manufacturing process optimization are keys to success in the increasingly demanding and competitive industry. Manufacturers need legacy part information for reference in designing current/future product lines – to say nothing of reverse engineering legacy parts to make them better while using modern computer-aided technologies for production. And with the glut of lawsuits and regulatory inquiries, manufacturers need to arm themselves with greater information resources and faster, easier access to their own dimensional, quality, and other manufacturing data.
Traditional inspection methods don’t solve any of these problems. CMM’s don’t archive data automatically (if at all), at best churning out an unverifiable table of numbers. Optical comparators and fixed gauges don’t output data, but instead rely on the non-reproducible eyes of inconsistent shop floor employees. Fortunately, modern technological solutions now exist that automatically and verifiably collect, analyze, report, disposition and archive all dimensional manufacturing process and resulting product information as decisionable data, for a myriad of uses.
Such data can be made demonstrably tamper-proof for defense against litigation and in regulatory requests for information, via checksums and digital signatures. Manufacturers can review past process and part data for quick and efficient reference, trending, SPC, CAD model creation, and many other applications. Best of all, self-contained integrated and automated Computer Aided Inspection (CAI) systems can be installed in manufacturers’ facilities, minimizing turnaround time, reducing iterations, and eliminating inspection delays.
Visit www.level3inspection.com or call us today to discuss how an in-house, archiving CAI system can suit your needs.