About You

oem smallv3

OEM Small

With a novel idea or technology in hand, getting to market quickly and efficiently is critical. Challenges of limited staff, pressures to meet deadlines, and lack of expertise is exactly where Kapstone can fit in to help you grow. We provide a turn-key product development solution and expert resources to act on your behalf as your outsourced team, or augment your core team as needed. Our proven methodology and QMS have stood the test of time (and FDA!).

OEM Large

If you have too many projects and not enough staff, Kapstone provides you the resources to finish projects on time and on budget.  Our process is designed to be flexible and allow our team to integrate seamlessly into your organization, meeting the demands of your quality system for regulatory and quality compliance.

Why trust Kapstone?
  • Our expertise in medical devices encompassing decades of experience and dozens of regulatory submissions
  • Our proven track record of commercializing products
  • Our flexibility to work in your or our systems, platforms, and processes

OEM Large


Expanding Internationally

Entering a new market can be daunting if you don’t know or understand the intricacies of the local regulatory environment. Whether you are looking to bring your product to the US or EU, we have the team and experts that are intimately aware of the latest regulations and best practices. Kapstone interacts regularly with both the FDA and Notified Bodies, and we can be your guide to establishing a presence to generate sales.


From conceptualization to commercialization, Kapstone will guide and educate you on the medical device product development process. We lead you to realize your idea, along with manufacturing and distributing the resulting product. Whether you want to sell your idea or create a company, Kapstone provides services for all aspects of product development and distribution, including:
  • Concept Generation & Design
  • IP Strategy & Monetization
  • Quality Assurance
  • Regulatory Affairs
  • Operations


Let's Start Creating

No matter where you are in the development process,
Kapstone Medical can step in and help guide you.