Simulation Software for 3D Design of Medical Devices
Are You Ready for UDI?Dassault Systemes
In an effort to improve the quality of information in medical device adverse event reporting, reduce recalls and improve patient safety, in 2007 the United States Congress passed legislation directing the FDA to develop regulations establishing the unique device identification (UDI) system for medical devices.
The UDI provides for more efficient identification and characterization of medical devices, enhanced reporting, reviewing and analysis of adverse event reports, facilitating the capability that problem devices can be identified, isolated and corrected more quickly.
In an effort to drive harmonization globally, thereby providing a single globally accepted system for positiveidentification of medical devices, the US FDA, the European Commission, the International Medical Device Regulators forum (IMDRF) and other country regulators have established a dedicated working group to provide guidelines and a model for global UDI implementation making safety and integrity of the global healthcare supply chain a strategic priority.
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