About EUDAPrep, founded by Sam Patton.

EUDAPrep was started in early 2026 after Sam Patton watched a regulatory affairs consultant spend days on a single EUDAMED submission. His background was operational systems for regulated industries: fintech, product infrastructure, automation for B2B. The work being done by hand was exactly the kind of mechanical, repeat-per-device task he had spent fifteen years building systems to remove.

The first version was a Python script that took an Excel sheet of device codes and produced a EUDAMED-compatible XML file. It did one thing: catch the rejection causes before submission. That single script saved a single client two weeks of back-and-forth with the competent authority.

The current product extends that script into a full preparation surface. It ingests unstructured product documentation, proposes the EUDAMED data fields, matches EMDN codes from the EC's official enumeration, and validates against the EC's schema and business rules before XML export. The principle is the same: catch problems before submission, and keep the human review record next to every approval decision.

EUDAMED rewards accurate first submissions and punishes inaccurate ones with rejection cycles measured in weeks. EUDAPrep narrows the gap between what the regulation requires and what your team actually has on file, by surfacing the specific fields that fail validation and the specific rows that need a human decision.

EUDAPrep does not file submissions on your behalf. It does not provide regulatory advice. The PRRC keeps the decision and the regulatory responsibility; the tool keeps the per-submission record next to every approval.