Kapstone Medical is a full-service, single-source medical device consulting firm that provides 
comprehensive and multidisciplinary consultation in Quality Assurance, Regulatory Affairs, Product Development, and Manufacturing Solutions. Our medical device experts help you navigate a cost-effective and expedited route to market. With Kapstone Medical, you hire one team instead of outsourcing 
multiple experts.

The Kapstone Difference

Flexible Business Model

Our team is uniquely positioned to onboard with your company at any point in the product life cycle. Whether you have a novel idea for new product development (NPD) or require specific consulting expertise, we can work with you.

Unparalleled Medical Device Expertise

We live and breathe medical devices. Together, we offer decades of industry experience with a proven track record in regulatory approval and device commercialization. Most importantly, we’re equipped to work across disciplines and across the globe.

Regulatory Affairs Consultation at Every Stage

Our consultants are experts in both U.S. and European regulatory governance, including FDA and CE Mark submissions. Our experts act as your regulatory representative, whether pre-commercialization or post-market, remediating challenges to compliance by devising an appropriate action plan and executing efficiently with your team.

Fully Customizable Quality Management System

Our robust QMS is ISO13485-ready and can be fully optimized for your company’s needs. A tried- and-true system, it has a decade’s worth of audits in improvements and is continually updated to latest guidelines. Most importantly, it is eQMS platform ready.

Risk Management

Risk analysis is central to the Kapstone offering. From project planning to manufacturing solutions, we leverage our decades of experience to identify and minimize the factors that could put your business or the patients you serve at risk.

Intellectual Property

Intellectual property is an essential component of the value we create for our clients. Our registered patent agent and team of experts are able to maximize that value by incorporating IP insights throughout the product development process. From a competitive landscape analysis to supporting a patent application, we ensure that your product is properly positioned, designed, and protected.

An Integrated Approach 
to Manufacturing Solutions

We take a fully-service approach to medical device consultation, and our manufacturing solutions are no exception. With a keen understanding of the interconnecting needs of engineering, regulatory affairs, and quality assurance, our manufacturing team is positioned to help you commercialize your product while minimizing risk. Leveraging a global network of suppliers and exhaustive list of materials, we’re prepared to launch your product to the masses.

How We Work With Our Partners

Whether you have a novel idea for new product development (NPD) or need specific consulting expertise, we can work with you. Our model is flexible so that you don’t have to be. After discussing and fully understanding your project need, we will propose a solution that will generally follow one of the bases below.
Full-Time Equivalent (FTE) Basis
With this method, the resources for your project can be customized in both specialty and amount to make our offering fit your needs. Employing Kapstone enables you to hire multiple experts at the price, for example, of one full-time equivalent (1.0 FTE). Working on a retainer basis, we use a fixed monthly price matched to the FTE amount, which can adjust with the needs of your project and organization.
If Kapstone is the right fit for your business or you have further questions, please reach out to our team.

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