Contract Manufacturing

Let Keystone do the heavy lifting. You’ve created an impactful product and your sales strategy is working. It’s time to produce product. Keystone is your turnkey resource for getting your product on the shelf and in your customers’ hands. Maximize your resources and focus on growing your business by leveraging Keystone for your sourcing, assembly, kitting, and packaging needs.

Prefer to offload warehousing and distribution? We can help there as well. We can warehouse and ship your products directly to you or your clients.   

We invite you to explore Our Focus, Capabilities, Approach, and further details on how we can serve you.

Our Focus

Our primary focus is the manufacturing, assembly, and kitting of sterile, single-use disposable devices.

Market areas include: wound care, imaging products, orthopedic systems, and others.

Our business model is tailored to meet your needs at virtually any level of production volume. Program production volumes range from tens of units per month to tens of thousands of units per month. We manage the entire supply chain, assist with sterilization validation and management, and provide warehousing and distribution services as needed by our clients. In many cases, we also qualify and manage suppliers and materials that are provided by our clients. For programs in the early stages, clients can also leverage our Product Development entity for complete development services including design, analysis, testing, design history file documentation, and overall program management.

Our Capabilities

Keystone offers a wide range of capabilities for clients seeking to outsource their medical device manufacturing needs, including:

  • Assembly
    • Kitting
    • Light Assembly
    • Laser Welding
    • Material Converting
  • Packaging
    • Sterile Barrier Packaging
    • Form Fill Seal Capabilities
    • Band, Bar, and Vacuum Sealing
    • Tray Sealing
  • Testing and Sterilization
    • Package integrity testing (burst, creep, peel, die penetration)
    • Sterilization validation development and management (EO, and Gamma)
    • End of line product testing
  • Warehousing
  • Distribution

Keystone delivers results utilizing a state of the art 41,000 sq. ft. facility which includes multiple controlled environments including Class 8 clean rooms and a Class 5 flow hood area. Keystone is FDA registered and ISO13485 certified.

Our Approach

Keystone engages each and every client first and foremost as your advisor and partner. Our primary goal is a successful launch for your program. Whether you are starting with a sketch on a napkin, or exploring the option of transferring your current manufacturing program, we can help. This holistic approach has proven to be successful over the last 20+ years and provides an effective, comprehensive resource for you and your team.