Medical Device Consulting That Gets You To Market
Full-Service Expertise for Pre- and Post-Market Medical Devices in the U.S. and EU
Full Product Lifecycle Consulting
The team at Kapstone Medical integrates with medical device companies at every stage of the product life cycle. We are uniquely positioned to onboard with your company at any entrypoint and progress your medical device forward with the guidance of specialized product developers, regulatory consultants and expert engineers.
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- Design And Development
- Testing
- Manufacturing And Packaging
- Quality Management
- Regulatory Affairs
View Our Process: The New Product Development (NPD) Roadmap
Download this step-by-step guide illustrating each phase of our new product development (NPD) process and how all of our services integrate.
Our Medical Device Services
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Quality Assurance
Whether working on new products or remediation, we are flexible to work within your existing quality system or provide QMS documents for you.
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Regulatory Affairs
With the latest regulatory knowledge, Kapstone will ensure you are compliant for all your premarket or postmarket needs.
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Product Development
Kapstone helps you design and develop new medical devices. We even offer Intellectual Property insights to assist with patentability and prior art searches.
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Manufacturing Solutions
With a single source philosophy, we uncover efficiencies in the manufacturing process, develop supply strategies, negotiate contracts for each step, and coordinate suppliers.
How We Help Our Clients Save Time and Money
John Kapitan, Founder/CEO
What Our Clients Have to Say
