Case Study: Leading International Medical Device Manufacturing Company achieves faster development-to-full-scale production with Critical Manufacturing

Moving faster from development to full-scale production

Leading International Medical Device Manufacturing Company needed to move a complex imaging-device line from development to full-scale production while replacing paper-based Device History Records and meeting FDA 21 CFR Part 11. The site combined semiconductor front-end, flat-panel and discrete assembly processes with long cycle times, split/merge batch traceability and high-value WIP, so they engaged Critical Manufacturing to deliver a flexible, self-manageable MES.

Critical Manufacturing implemented its modern MES in three months, deploying fault-tolerant production/staging/dev environments plus features like complete eDHR, operator certification, fabLIVETM 3D shop-floor visualization, integrated maintenance, exception management and SPC (over 80 charts and 600+ data parameters). The solution delivered real-time data, reduced manual errors and rework, improved traceability for split/merged lots, faster decision making and better OEE, and Critical Manufacturing’s CSV package can cut validation time and cost by more than 50%, enabling faster, higher-quality product ramp-up.