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 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 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.