SigmaPro Engineering & Manufacturing, LLC

SigmaPro Engineering and Manufacturing is a Texas-based precision injection molding specialist serving medical device OEMs and Tier 1 suppliers. The company manufactures complex plastic components for minimally invasive surgical devices, drug delivery systems, diagnostic and analytical consumables, and optical/wearable medical assemblies. SigmaPro operates a 12,000 sq. ft. ISO 13485 and ISO 9001-certified facility in Fort Worth with Class 8 cleanroom capabilities for molding, assembly, and packaging. The facility integrates in-house tooling maintenance, coordinate measuring machines (CMM), optical inspection systems, and real-time process data monitoring to achieve micron-level dimensional tolerances (±4 microns) and validated production. The company is FDA-registered and maintains MDR compliance alignment. Services include design for manufacturability (DFM) consultation, tooling engineering, process validation, and scalable high-volume production. SigmaPro serves North American and European medical technology markets with emphasis on biocompatibility verification and regulatory documentation support for complex, high-precision plastic components.