Kapstone Medical was founded to make medical device development easier, more efficient, and even more enjoyable. We do that by providing a single-source solution for medical device devices, big to small, allowing them to check multiple competency boxes under the same roof. No need for multiple hires: your company can save money and time by bringing our team on board, whenever and wherever you need us.
We offer seasoned, multifaceted expertise in:
"I liked the 'one-stop shopping' aspect, where only prototype fabrication was outsourced." - Jan 2011 - July 2015 Project Dates
[For years, world-class surgeons loved our 'one-stop' engineering and regulatory approach, but the only friction point was waiting on outsourced prototyping. We listened. That is exactly why we built ISO 13485 Contract Manufacturing through our Kapstone Manufacturing facility in Charlotte—to bring that final piece of the puzzle in-house for our clients.]
"Kapstone Medical designed and built surgical instruments for a medical device firm, including prone lateral spinal access instruments, retractors, and spinal fusion implants. They also handled IP protection."
I started a very complex project with Kapstone. What I found was a group that was incredibly responsive to my needs and receptive to my ideas.
Kapstone has done a marvelous job. Everything from prototyping, intellectual property development as well as helping me get to market.
Download our New Product Development (NPD) Roadmap to take a deeper dive into our seamlessly integrated process.
See the benefits of working with an ISO 13485-certified QMS partner who can audit your existing system or help you install a new one.
Explore our end-to-end manufacturing capabilities, from experienced material selection through to efficient commercialization.
Build confidence in your regulatory strategy with help from Kapstone, an experienced regulatory partner who can help you identify the most compliant, efficient path to clearance.
Developing an innovative product will only go so far without a plan to get it to the field and in users’ hands. Let Kapstone assist with the go-to-market strategy.
