Complete Compliance Toolkit
UDI & Device Registration Toolkit
6 ready-to-use templates that streamline your UDI implementation, GUDID submissions, and global device registrations — so you can focus on getting your device to market.
Why Regulatory Teams Choose This Toolkit
Save 40+ Hours
Skip months of research. Every template follows current FDA and EU MDR requirements.
Avoid Costly Mistakes
Built from real-world submissions that passed FDA and Notified Body reviews.
Global Coverage
From FDA GUDID to EU EUDAMED — manage registrations across every major market.
What's Included
6 professionally crafted documents, ready to customize and submit
UDI Implementation Plan Template
FDA 21 CFR 830
GUDID Submission Checklist
FDA AccessGUDID
EUDAMED Registration Checklist
EU MDR
Device Registration SOP
Standard Operating Procedure
UDI Label Requirements Worksheet
Direct marking + label placement
Global Device Registration Tracker
Spreadsheet template
Trusted by Regulatory Professionals
“This toolkit saved us weeks of research and thousands in consultant fees. We passed our FDA UDI audit on the first attempt.”
Sarah Chen
VP of Regulatory Affairs, MedTech Solutions
“The EUDAMED checklist alone was worth the investment. Clear, actionable, and exactly what we needed for EU MDR compliance.”
Dr. Michael Torres
Quality Director, Precision Devices Inc.
“We used the Global Registration Tracker to manage device registrations across 12 countries. Incredibly well organized.”
Jennifer Walsh
Regulatory Manager, CardioVascular Systems
Get Your Complete Toolkit Today
Instant download. Start your UDI implementation in minutes, not months.
One-time payment of $247. No subscription.