Case Study: Sorin Group achieves rapid FDA UDI compliance with Oracle Agile Product Collaboration

The First Company in Europe to Meet Unique-Device Identifier Compliance Requirements for Medical Devices

Sorin Group, a Milan‑based global medical‑device company specializing in cardiovascular surgery and rhythm‑management technologies, faced an urgent regulatory challenge after the FDA’s 2013 UDI mandate required unique‑device identifiers and submission of product data to the FDA’s global database. Meeting tight deadlines meant Sorin had to source and cleanse legacy UDI data across R&D, production, quality, and regulatory teams worldwide and centralize accurate device information to avoid losing access to the U.S. market.

Sorin deployed Oracle’s three‑step UDI solution based on Agile Product Collaboration, implemented with Oracle partner Inspirage, and went live in under four months. The solution automated capture, cleansing, validation, and centralized FDA‑compliant archiving of UDI data, allowing Sorin to become the first company in Europe (and second worldwide) to achieve UDI compliance, avoid business disruption, preserve U.S. market access, and improve traceability and data quality.

Sorin Group

Cesare Varzi

Vice President, Corporate IT