Custom Manufacturing, Inc.

Custom Manufacturing Incorporated is a non-automated contract manufacturer specializing in single-use and disposable medical devices, electrosurgical devices, and cardiac insulation pads classified as Class I medical devices. Founded in 1996, the company provides comprehensive manufacturing, assembly, packaging, and labeling services for medical device manufacturers and OEMs. Manufacturing capabilities encompass simple to complex assembly operations, including kit assembly, with flexibility to accommodate client specifications. Packaging services include pneumatic, heat, impulse, and other sealing methods ensuring packaging integrity and seal strength. The company offers detailed labeling capabilities from basic information labels to Microscan LVS barcode labels. The facility includes a state-of-the-art ISO Class 7 controlled clean-room environment certified per ISO Standard 14644-1:2015, enabling production of sterile and contamination-controlled medical devices. The company also manufactures non-medical devices. Operating from Elbert, Colorado, Custom Manufacturing serves medical device manufacturers requiring domestic contract manufacturing with quality assurance and regulatory compliance. The facility's large production area supports simultaneous manufacturing, cleaning, packaging, labeling, and assembly of multiple product lines.