Keystone Solutions

Keystone Solutions Group is a medical device contract manufacturing and product development company located in West Michigan. Since 1997, the company has collaborated with customers around the world in offering turn-key medical device product development and contract manufacturing for sterile, single-use, reusable and electro-mechanical devices. Keystone’s operation is FDA registered and ISO13485:2016 certified, and provides assembly, kitting, packaging, converting and sterilization management services for single-use disposable and reusable medical products. Our state of the art facility has multiple clean room environments and includes a wide array of assembly and packaging capabilities. We offer a proprietary validated sterilization cycle for various packaging configurations. Taking it beyond the core contract development and contract manufacturing services, Keystone provides unique pathways to product launch through a truly collaborative approach with clients. Regulatory, IP, and other commercial challenges are tackled utilizing solutions that break the mold of typical OEM/CM relationships.