About Us

The Kapstone Medical Mission is to Inspire, Equip and Guide.

Our Management Team

John Kapitan

CEO

Mike Burgan

COO

Justin Rowland

Director of Business Development

Carolyn Guthrie

Director of Regulatory Affairs & Quality Assurance

David Walsh

Director of Engineering

Katelyn Jessup

Regulatory & Quality Manager

The Integrated Project Team at Kapstone Medical

The expertise of our team encompasses decades of experience and dozens of regulatory submissions.

As a result of this experience, each member of the Kapstone Medical team brings a unique suite of capabilities that are both expansive and highly specialized. It is precisely this synergy of broad-reaching knowledge and niche intelligence that allows our team to conduct each phase of medical device development and regulation with impressive attention to detail at the micro level, while planning for outcomes at the macro level to advance your product forward.

Our Proven Track Record of Commercializing Products Worldwide

Customers
Served

Products
Launched

Regulatory
Submissions

Who We Serve

Whether you are a device manufacturer, your product is expanding internationally, or you’re simply an inventor with a great idea for a medical device, we can work together.

Large OEM

If you have too many projects and not enough staff, Kapstone provides you with the resources to finish projects on time and on budget.

Expanding Internationally

Whether you are looking to bring your product to the US or EU, we understand the intricacies of the local regulatory environment, interacting regularly with both the FDA and Notified Bodies.

Individual Inventors

From conceptualization to commercialization, Kapstone will guide and educate you on the medical device product development process. We lead you to realize your idea and manufacture and distribute the resulting product.

Startup OEM

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.

Learn more about how we work with our partners

Why Kapstone

Our Certifications Include

Company

ISO 13485 Certified & FDA Registered

Regulatory Affairs

RAPS Certified

Engineering

Certified SolidWorks Professional

Quality Assuance

Certified Quality Auditors

Intellectual Property

Registered Patent Agent

To Learn More About our Integrated Project Team at Kapstone Medical, View our Team Organization Chart

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A Message From Our Team

“If we’re waiting on parts to be made or tests to be run, we can fill that time with downstream activities in a way that makes the best use of our project team. This keeps them fully engaged in the project.”