Federal regulation requires Unique Device Identification (UDI) labels be present on all packaging for implantable devices by September 2015. UDI 360 is a cloud hosted application providing a 360-degree view of UDI marked implant devices highlighting lifetime performance metrics. This software links the tracking, life-cycle events, and stability of the implanted device, resulting in full spectrum visibility to the FDA, the hospital, the manufacturer, and the patient.
UDI 360 provides a new level of patient empowerment. Implant recipients can now monitor their devices 24/7 for product recalls or any other issues by part number and lot number. This interface allows patients to maintain information unique to their device, providing more flexibility and insight into managing their healthcare. Device information can also be easily integrated into each provider’s Electronic Health Record (EHR) / Electronic Medical Record (EMR).
Please contact UDI360Info@4mresearch.com for additional information.
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Supports clinical outcomes, enables device purchasing decisions, and empowers decision makers with actionable data.
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UDI 360 requires less than an hour to train OR personnel. No software to install. Any device with Internet connectivity can utilize UDI 360.
The process of tracking tissue and devices is simplified and streamlined. Answers regarding existing inventory and implanted devices and tissues is a click away. Manufacturer barcode scanning reduces user input error.
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Harness the power of the UDI data. UDI 360 is the key to integrating metrics regarding implant performance, device safety, and accurate product identification.
Uses FDA mandated UDI markings to comply with current Joint Commission medical device tracking standards and facilitates easy identification of recalled items.
UDI 360 enables effective communication between departments, hospital systems, patients, and manufacturers.