Ardiem Medical, Inc. is a full-service medical device design and manufacturing company specializing in small run and prototype builds, including custom neuromodulation devices such as electrodes, stimulators, and control units. The company operates a Class 10,000 clean room and provides contract manufacturing, engineering services, and prototyping for medical devices.
ISO13485 compliant
Compliance program
CadenceCadence is a full-service medical device contract manufacturer that takes complex products from early design through finished-device production and supply chain management. With approximately 800 employees and locations across the United States and Costa Rica, the company combines vertically integrated manufacturing with particular expertise in difficult-to-machine components and miniature medical parts. Cadence operates FDA-registered, cGMP-compliant facilities and maintains ISO 13485 certification, including certified ISO Class 7 cleanrooms for demanding assembly work.CRANBERRY TOWNSHIP, PA
Proto Dev and Fab, LLCFounded in 2020 from James Rogers’s garage machine shop, Proto Dev and Fab develops medical devices and turns difficult design ideas into working prototypes. The company combines product-development and design-for-manufacturing guidance with hands-on fabrication, including prototype work such as the Project Spiritus rescue-ventilation device. Rogers brings experience as a machinist and design engineer, along with multiple granted and pending patents and a master’s degree in engineering.MILFORD, OH
Integer Holdings CorporationInteger Holdings Corporation develops and manufactures medical devices and components for medical device companies, with a focus on cardio and vascular, neuromodulation, and cardiac rhythm management markets. The company operates as a large contract development and manufacturing organization, combining engineering and manufacturing expertise through brands including Greatbatch Medical and Lake Region Medical. Its history spans 80 years of industry innovation and manufacturing.CLARENCE, NY
ARCH Medical SolutionsARCH Medical Solutions brings together a nationwide network of FDA-registered facilities to contract-manufacture tight-tolerance medical implants, instruments, and components for OEMs. Its precision work spans orthopedic devices and surgical-robotics parts, with engineering support and prototype-through-production services built into the process. The company also develops MedTorque silicone-handled surgical instruments and operates under ISO 13485-certified quality systems.QUAKERTOWN, PA