Full Lifecycle Support for Medical Device Quality Assurance

Kapstone takes a holistic approach to quality assurance, more than just “checking the boxes”. Whether you’re in the market for a new QMS or need to improve the one you have, we can help. Whether you need quality resources to bolt on to your development team or are looking to do comprehensive product development with Kapstone, we can integrate at any stage in the product lifecycle.


Quality Management System

Get the benefits of Kapstone’s QMS experience right from the start. We’ll help you improve or remediate your existing system or we can provide you one off-the-shelf. If you’re looking to obtain ISO 13485 certification, we can help with that too.


See the benefits of transitioning to an electronic quality management system (eQMS) and how Kapstone can help you get there.

Gap Analysis

Identify your current areas of noncompliance and opportunities for improvement with help from the experienced team at Kapstone.


We’ll perform audits that reveal opportunities for improvement and prepare you for US FDA, EU MDR, and ISO 13485 inspections. If you’re preparing to obtain an ISO certification, rest assured; we’re ISO-certified ourselves, so we know how to set you up for success and guide you to the finish line.

Quality Support

Lacking the resource expertise or capacity? Kapstone can provide Quality Engineering or Quality Assurance resources to product development projects or more generally in your Quality department.

What Our Clients Are Saying

I 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.

Dr. Garcia Bengochea, Neurosurgeon
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.

Wyatt Geist CEO, Safewire Inc.

See Our Process in Action

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