Medical Device Consulting That
Gets You to Market

  • About Kapstone Medical
  • Who We Serve
  • Our Certifications

Product Realization for Pre- and Post-Market Medical Devices in the US and EU

As a full-service provider, Kapstone Medical is more than just an engineering firm or regulatory consultancy. Our mission is to inspire, equip, and guide medical device companies to market, providing a single-source solution to all the challenges along the way. While we’re experts in development, manufacturing, regulatory affairs, quality system implementation and more, we’ll adapt our model to your unique needs and onboard whenever you’re ready for us. We’re flexible in our process so that you don’t have to be.

Our Proven Track Record of Commercializing Products Worldwide




Customers Served




Products Launched




Regulatory Submissions

Our Services:


New Product Development (NPD)

The development and approval of a new medical device follows a process with significant effort and activity – and oftentimes is longer than anticipated. We boil down the complex journey to market into discrete phases, leveraging our organizational know-how and industry expertise to ensure that your project meets (or exceeds) your critical early benchmarks. In addition, our in-house registered patent agent can assist with intellectual property research to ensure that your device is properly positioned, protected, and ready for the competitive marketplace.


Quality Assurance

Whether performing an audit or a gap analysis of your quality system, documentation, or company, we understand international regulatory requirements and can ensure you have the best practices for success and compliance. We can work with your quality management system, or provide you the Kapstone ISO13485-ready and electronic-ready QMS. Our quality resources fit in at any time — pre- or post-commercialization.


Regulatory Affairs

With our decades of regulatory experience and deep understanding of the latest guidance, our medical device consultants are poised to deliver regulatory strategies that will give your products the clearest and fastest path to approval. Whether a 510(k) submission in the US or a technical file in the EU (or other international submission), we can compile and submit the necessary documentation and act as your go-between with regulatory bodies. We also offer our regulatory services to represent or train your regulatory department.



Finding an appropriate manufacturer with the right combination of quality, price, and lead time can sometimes be challenging in the medical device industry. Kapstone has the years of experience to find and manage the numerous suppliers typically required to produce a medical device from raw material to the clinical setting. Through our Kapstone Manufacturing arm, we can also provide competitive prototyping and production quotes for your product.


Commercialization Support

We partner with you right up through the finish line - and beyond. Supplementing our new product development process, we also offer an extensive array of operations and commercialization support services. 

Our Latest Resources:

View All Resources

Design Control Traceability Matrix: 5 Essentials for Medical Device OEMs

Every aspect of the medical device life cycle — from concept to post-market activities — is subject to [..]

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How medical device consultants guide successful 510(k) submissions

If a medical device manufacturer intends to bring a product to market in the United States, it must notify the [..]

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4 Steps to Developing a Successful Medical Device Commercialization Strategy

An effective medical device commercialization strategy is imperative for successful product launch and scaling. [..]

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What Our Clients Are Saying

Kapstone has done a marvelous job. Everything from prototyping, intellectual property development as well as helping me get to market.

CEO of startup company

See Our Process in Action

Download our New Product Development (NPD) Roadmap to take a deeper dive into our seamlessly integrated process.