UDI Management — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete UDI management system covering ISO 13485, EU MDR Art. 27 + Annex VI, 21 CFR 830 (FDA UDI Rule), MDCG 2018-1 Rev.4. Multi-issuing-entity ready (GS1, HIBCC, ICCBBA).
What’s included:
- SOP-ISO-14 UDI Management — Basic UDI-DI / UDI-DI / UDI-PI assignment, EUDAMED submission, label coordination, change-driven UDI updates per MDCG 2018-1.
- F-ISO-14.1 UDI Master List (Excel — 3 tabs) — master register with conditional formatting on EUDAMED status, 18-column tracking incl. GS1/HIBCC/ICCBBA issuing entity.
Why this package: UDI failures = market access blockers. This package gives you a robust UDI tracking system aligned with both EU and FDA expectations.
Format: Microsoft Excel (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.