Medical Device Regulatory Submission Consultation

Medical device companies sometimes think of regulatory affairs as a faraway part of the development lifecycle. Why worry about FDA medical device regulation when you don’t even have an engineer available to work on your project? Why familiarize yourself with EU medical device regulation when you haven’t aligned on your device’s intended use?

While regulatory submission and approval occur towards the end of the development lifecycle, companies can save time and money by integrating regulatory affairs early and often.

We do just that at Kapstone, leveraging our decades of experience to help our clients:

  • Create a regulatory plan at the concept stage, outlining a streamlined path to regulatory clearance/approval and preservation of intellectual property
  • Identify predicate devices to further streamline regulatory approval
  • Identify required tests for each global market, avoiding wasteful spending on unnecessary tests and ensuring critical tests are not omitted
  • Differentiate between requirements for US and EU submissions (and other markets)
  • Liaise with regulatory bodies
  • Prepare required documentation

Kapstone’s regulatory specialists can step in at any stage in the development or lifecycle process. While we recommend integrating as early as possible, we can support closer to the submission time or when adding a new market to an already established device.

Navigating FDA Medical Device Regulation

Kapstone Medical is here for you every step of the way as you plan your submission strategy for the US market. We help you to properly classify your device, identify predicate devices (if required), prove substantial equivalence, and compile all proper documentation for submission.

We typically recommend holding an FDA pre-submission meeting (unless the pathway is very straightforward or the device is not particularly innovative). Early conversations with FDA typically reduce significant questions arising later during the final device submission.

When the time is ready, Kapstone supports efforts for the following FDA submissions:

  • Q-Submission (e.g. pre-submission)
  • Premarket Notification (aka 510(k) and including Traditional, Special, & Abbreviated)
  • De Novo
  • Premarket Approval (PMA)
  • Emergency Use Authorization (EUA)
  • Investigational Device Exemption (IDE)

Specifically, Kapstone conducts the following regarding FDA submissions:

  • Writing technical and supporting documentation
  • Compiling submission elements
  • Filing submission with FDA, including latest electronic copies
  • Corresponding and coordinating with FDA
  • Addressing any Additional Information requests by FDA

Planning and Submissions for EU Medical Device Regulation

Kapstone can help you plan and execute on a submission strategy for the EU. As experts in EU MDR and obtaining a CE mark, we can help you navigate those complex and ever-changing requirements. In parallel, we’ll help you properly classify your device and build the technical documentation.

Other Regional Medical Device Submissions

Kapstone has experience, expertise, and knowledge around the globe meaning that we can ensure you are prepared to launch in other major markets as efficiently as possible.


Other regions that we have capabilities include:

  • United Kingdom (UKCA Mark)
  • Canada
  • Japan
  • Brazil
  • Mexico
  • Australia
  • New Zealand
  • South Africa

Achieving Compliance for Commercialization

The work is not done after regulatory clearance/approval is gained. In most markets, device and company registration is required. If not already prepared, your quality management system (QMS) may need updates to be ready for a new region’s requirements. Kapstone can work for you to make sure you are completely compliant to regulations.


For support with QMS, visit our page here.

For support with Commercialization, visit our page here.

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