Determining Software as a Medical DeviceIt is critical to first determine if the software article is a Device Component, a Device Accessory, or a Standalone Device. A Device Component is any raw material, substance, piece, part, software, firmware, labeling, or...
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UDI Implementation Tips and GDSN Data Management
Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech Tracking medical devices throughout the healthcare supply chain and delivery system has proven...
Reed Tech® Introduces Reed Tech SingleSource™ for Medical Devices Supporting UDI Requirements around the Globe
HORSHAM, Pa., March 25, 2019 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech), a leader in data management and analytic services and solutions for the Life Sciences industry, announces the launch of Reed Tech SingleSource™ for Medical...
White Paper: Global & EU UDI Data Management Challenges & Solutions
The UDI product data submission process can be arduous without the right expertise and tools. Failures in the process can have a significant, negative impact on a medical device manufacturer’s bottom line. In light of regulatory and marketplace demands, proactive...