Medical Device Contract Manufacturing
Complex, single-use medical devices
We are focused exclusively in the medical device industry and provide turnkey medical product outsourcing services. Our services include product development, design for manufacturability, process development including validation, packaging validation, and sterilization management. We work with startups, mid-size, and large medical device OEM's to launch next generation medical devices or when transitioning legacy products to outsource medical device manufacturing.
We maintain ISO Class 8 (Class 100,000) cleanrooms in Rochester, NH (USA) and Tijuana, BC (Mexico) used for medical device assembly and sterile barrier packaging. We build confidence in manufacturing medical devices of the highest quality by utilizing process control and LEAN manufacturing techniques that provide our clients with increased throughput, higher quality, and reduced cost of goods sold (COGS) for their medical devices.