Inspirage customer Sorin Group becomes the first company in Europe to meet the U.S. FDA’s Unique Device Identifier (UDI) compliance requirements for medical devices.
Sorin Group is a global medical-device company and a leader in the treatment of cardiovascular diseases. The company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac-rhythm disorders. Headquartered in Milan, Italy and listed on the Milan Stock Exchange, Sorin Group is a global company. Each year, over a million patients are treated with its devices in more than 100 countries. More than 10% of Sorin’s revenue is dedicated to research and development (R&D). The company’s R&D centers employ over 15% of Sorin’s staff around the world. Multidisciplinary teams bring together researchers from different backgrounds to offer a broad range of technical and scientific expertise.
In September 2013, the US Food and Drug Administration (FDA) ruled that medical devices distributed in the United States must carry a unique-device identifier, or UDI, which will help the FDA identify product problems quicker, target recalls more effectively, and improve patient safety. The system established by this rule requires the label and device package of each medical device to include a UDI in a plain-text version and in a form that uses automatic identification and data-capture technology. The labeler must also submit product information concerning devices to FDA’s Global Unique Device Identification Database. Companies that miss the submission deadline can be restricted from selling their products in the US market.
The scope of this effort, combined with the short time line within which to comply, made UDI compliance a top priority for Sorin Group. The company started a global initiative across different business units and manufacturing sites and departments, such as R&D, design, production, quality assurance, and regulatory affairs, which impacted all therapeutic areas. The scope was to first source and cleanse legacy UDI data globally, and then centralize and submit device information to the FDA. Sorin Group applied the same UDI concept internally to increase the efficiency, quality, and traceability of its medical devices.
Sorin Group, a 2014 Inspirage Innovation Partner of the Year award recipient, leveraged the Inspirage and Oracle UDI Solution to quickly and effective achieve compliance.
“With the Oracle/Inspirage Unique Device Identifier solution, we were certain that we would get a global, well-tested, and collaborative-enterprise solution to accelerate transfer and standardization of legacy unique-device identifier attributes, streamline cross-functional processes, and ensure compliance.”
– Cesare Varzi, Vice President, Corporate IT, Sorin Group