Kapstone partners with inventors to rapidly develop and commercialize new medical devices. We provide services for all aspects of products development & distribution, including quality assurance, regulatory affairs, supply chain management and IP monetization.
We can look at projects from multiple angles due to our background in engineering, quality and regulatory affairs. What we provide is not just an engineering solution or a quality system, but rather a creatively balanced result that takes into account the various requirements of a medical device organization.
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.
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.