The certification is already in place
You start on a platform that is already FDA-listed. The technical documentation exists, and keeping it current is our job, audit after audit.
- FDA-listed: registered and listed with the U.S. FDA
- ISO 13485 quality management, audited regularly — the standard FDA’s QMSR incorporates by reference
- CE-marked, Class IIa under the EU MDR, so the same pathway can scale to Europe later without a second procedure






