Contract medical device manufacturing of disposable and durable medical goods. Manufacturing, assembly, packaging, distribution and fulfillment. We provide turnkey manufacturing solutions from prototypes and pilot builds to full-scale production, Keystone will support your medical device manufacturing needs. Give your supply-side challenges to Keystone to develop and manage so you can concentrate on what you do best—selling your product. Whether you need help with complete assemblies, accessories or subassemblies, Keystone has the expertise and experience to manufacture, assemble, package, sterilize, and distribute your product.
Keystone partners with our customers. Our operation is FDA registered and ISO 13485 certified. Keystone medical device manufacturing has robust processes and adheres to all aspects of our GPM Compliant Quality System. Our experience ranges from Class I and II disposable products to more complex durable medical equipment (DME) and electro-mechanical assemblies. Keystone has the expertise to help launch and sustain the commercialization of your medical product and can even help build your Quality System and your Device History File (DHF) documentation. Whether you’re an inventor, Start-up, specification development, or an established OEM…contact us for your next project.
Keystone Manufacturing performs contract packaging, kitting, assembly, labeling, and sterility management services, including CE marking. We have controlled environment and certified clean room facilities and can manage the entire process from concept and product procurement to warehousing & distribution including CE marking. Our flexible manufacturing space allows you to leverage our infrastructure from prototype and validation through to high-volume production.
supply chain management
Along with our design and product development expertise, Keystone has vast knowledge and sourcing experience to help specify, find, and source the best components for your medical device. Give your supply-side challenges to Keystone to develop and manage…so you can concentrate on what you do best…selling your products.
warehousing, Distribution and fulfillment
Now that the product is finalized and successfully launched…Keystone offers warehousing, distribution and fulfillment services. From Kanban and Vendor Managed Inventory (VMI) to customer service and order fulfillment, we work with our customers to assure the supply meets the demand.