Introduction Design transfer is one of the most consequential moments in a medical device startup’s journey. It is [..]
Customers Served
Products Launched
Regulatory Submissions
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 registered patent agent can assist with intellectual property research to ensure that your device is properly positioned, protected, and ready for the competitive marketplace.
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.
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.
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.
Introduction Design transfer is one of the most consequential moments in a medical device startup’s journey. It is [..]
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For medical device startups and OEMs in Europe and Asia, the United States has always been an important [..]
"They strive to make the project go smoothly and with the utmost quality."
Kapstone Medical delivered the QMS system with high standards, enabling the client to take it to any contract manufacturer. The team offered training for the client and communicated well via in-person and virtual meetings. Kapstone Medical showcased excellent project management and technical skills.
"Our previous system had gaps we needed to rectify, and the updated QMS helped us achieve FDA compliance."
Kapstone Medical delivered the client's new implant, packaging, and sizers, updated their DHF, and completed their QMS, enabling the client to achieve FDA compliance. The team completed the project on time, with some expected minor delays. Their CEO was also hands-on and always involved."
"We have worked with them for more than four years and first engaged Kapstone in July 2016. We have enjoyed a good relationship to date.
We have relied on Kapstone in the formation and development of our company and found them to be a reliable and consistent service-provider in the following areas:
QA including obtaining and maintaining ISO 13485:2016 certificationI started a very complex project with Kapstone. What I found was a group that was incredibly responsive to my needs and receptive to my ideas.
Kapstone has done a marvelous job. Everything from prototyping, intellectual property development as well as helping me get to market.
Download our New Product Development (NPD) Roadmap to take a deeper dive into our seamlessly integrated process.
