Since our founding, we’ve worked with medical device companies of all sizes in all stages of development. We have years of experience working with larger, established companies, helping them find efficiencies in old processes or transition staff to new ones. If you have too many projects, not enough staff, or just need another pair of eyes on your process, Kapstone can help. We’re comfortable working in other companies’ quality systems and we understand big organizations. Let Kapstone Medical provide you the resources and strategic counsel to finish your projects on time—and on budget.
Some of the most exciting work and innovative products come out of start-up medical device OEMs. We’re used to working with small companies and we know better than anyone that it is essential to get to market as quickly as possible without sacrificing quality. If you’re feeling the pressure of small staff, limited expertise, or looming deadlines but don’t quite know what to do next, Kapstone Medical can help. Together, we’ll find an efficient path to approval and set your team up for organizational and commercial success.
Whether you are looking to bring your product to market in the United States or Europe (or other geographies), Kapstone Medical can support your initiative. We understand the intricacies of various local environments and can help to bridge the gap to international market success. Our regular interactions with the FDA and Notified Bodies (and other regulatory bodies) mean that we’re comfortable in international regulatory environments. Lean on Kapstone’s counsel and experience.
Running a one-person show? New to the medical device industry? Kapstone Medical is here to round out your team and support your next great invention. We’ll guide you through conceptualization to commercialization, educating you on the medical device development process along the way. You can bring our expert consultants on board in any capacity that works for you: engineering, IP strategy, quality assurance, regulatory affairs, manufacturing, commercialization, or a combination of services. Whichever you choose, you can rely on Kapstone’s experience to make your path to market as smooth as possible.
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.
Dr. Garcia Bengochea, Neurosurgeon