Kluge Design LLC

Kluge Design LLC (KDI) is a precision contract manufacturer specializing in low-volume, complex medical device development and production since 1982. The company designs and manufactures complete medical device systems and mechanical/electro-mechanical subassemblies, with capabilities including CNC machining, custom cable assemblies, laser marking, and design-for-manufacture (DFM) engineering. KDI handles the full manufacturing lifecycle—from product development and prototyping through production, finished goods storage, order fulfillment, and complaint handling/repair services. ISO 13485:2016 certified and FDA-registered, KDI serves OEM partners across cardiology, orthopedics, diagnostic imaging, and other medical sectors, with annual project revenues typically below $1–5M, positioning it as an ideal partner for specialized, lower-volume medical device projects requiring engineering collaboration and rapid completion.