Specially Designed Software May Aid Devicemakers With UDI Compliance

October 14, 2013
Devicemakers may benefit from using specially created software to comply with the FDA’s new unique device identification submission and tracking requirements, rather than creating their own systems, some experts say. If the software “can assure consistent compliance … envision the various scenarios by which it will be used and can be depended upon, it will be useful,” Steven Niedelman, lead quality systems and compliance consultant at King & Spalding, told D&DL.
Devices & Diagnostics Letter