US FDA Establishment Registration and Device Listing support, required before marketing medical devices in the United States.
Manufacturers, and often their distributors, must register their establishment and list their devices with the FDA before marketing in the United States. We help prepare and manage the registration and listing process.
This is typically the first regulatory step before pursuing 510(k) clearance or another applicable FDA pathway.
Medical device manufacturers and initial importers placing devices on the US market.
The regulatory step required before you can sell in this market.
Well-prepared submissions face fewer rounds of questions.
Get the classification and documentation right the first time.
We know what this specific regulator actually expects.
We stay engaged as requirements evolve, not just at submission.
A cleared regulatory pathway makes partners more comfortable.
The same straightforward path applies across every standard and service we support.
Gap review & scoping
Build required documentation
Assessment / submission
Certificate / clearance issued
Tell us a bit about your organization and we'll put together a straightforward, competitive quote.