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From FDA Approval to the Operating Room


our most precious asset is time and you probably do not have enough of it, nor the desire, to audit and select the best manufacturers around the country for your invention.

Our Strategic Sourcing department is the perfect solution. We will negotiate a supply arrangements on your behalf with first-in-class FDA-compliant medical device manufacturers with a proven track record with our organization.

We will develop for you supply strategies and negotiates contracts for purchases of raw materials, packaging, logistics, information systems, capital projects, labor, services and on-going operational needs.

Realize Your Idea


lightbulb-redSet-up & Maintain Your Quality System (SOP, ISO)

Kapstone Quality Assurance professionals are trained to set-up and maintain your quality system so that you can stay focused on developing your invention.

Our Quality experts will set-up your Quality System, create your SOP (i.e Standard Operating Procedures) and train and support you and/or your team to the point of getting your ISO Certification and passing FDA audits.

We are also able to serve our customers in realizing international regulatory requirements for medical devices.  Contact us for more information.

Kapstone Medical Device IP Fit StrategyProtect Your Idea With IP Fit

An effective IP strategy is a direct extension of your overall strategy. Intellectual Property protection has an enormous impact on the value of your invention.

To address this key point, we have created “IP Fit”. “IP Fit” is a new more efficient and cost-effective way for you to orchestrate your IP strategy.

Diane Dobrea, our in-house Intellectual Property Specialist, will lead you step-by-step through the IP value creation process, on time and on budget. Call us now to discover how our “IP Fit” can help you.

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