CoForge Medical

Your Engineering, Prototype, and Subassembly Partner for FDA-Regulated Devices and Non-FDA Devices

CoForge supports medical OEMs and innovators by accelerating the development of Class I & Class II, 510(k)-aligned medical devices, electro-mechanical assemblies, and capital equipment subsystems.

We specialize in engineering, prototyping, documentation support, subassembly builds, and field service—all aligned to FDA expectations.

We operate as an extension of your engineering and manufacturing teams, helping you move faster from concept to clinical-ready hardware.

Where We Fit in the MedTech Ecosystem

You own the device and the FDA submission.

We help you get it built, tested, and ready.

CoForge partners with medical OEMs who:

●     develop Class I & Class II medical devices requiring 510(k) clearance

●     build electro-mechanical medical equipment and imaging subsystems

●     need rapid prototyping, design refinement, and engineering bandwidth

●     want help producing subassemblies, wiring, and mechanical modules

●     require support documenting designs, materials, and builds for FDA compliance

You maintain the FDA “manufacturer of record.”

We help you design, refine, prototype, assemble, document, and support the subsystems that go into your cleared device