C2C Development, LLC

C2C Development, LLC is an FDA-registered, ISO 13485:2016-certified contract manufacturer and product development firm specializing in medical device design, prototyping, and low-volume manufacturing. The company operates a certified ISO 7 (Class 10,000) cleanroom environment and serves medical device innovators across laparoscopic, endoscopic, orthopedic, intravascular, neurological, stereotactic, and drug delivery applications. Services include comprehensive design control and prototyping using 3D modeling, 3D printing, conventional machining, and CNC machining; component sourcing and supplier qualification under ISO 13485 quality systems; assembly and packaging operations including kitting, cleaning, and inspection; verification and validation testing including packaging seal integrity, shelf-life, and mechanical/functional testing; sterilization management and laboratory testing coordination; and regulatory strategy consultation and submission support. The firm specializes in manual and semi-automated assembly for products that larger OEMs may not accommodate, enabling manufacturers to scale from pilot production to commercial release under either C2C's or the client's quality system. Clients include Medtronic, FHC, Monteris, and other established medical device manufacturers.