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What's Unique Device Identification Implementation & Compliance?

As a medical device manufacturer, you're faced with some of the most challenging demands in business. Then, if you factor in the need to reduce costs and increase profitability to remain competitive, it quickly becomes obvious that managing processes without a proper structure is a dangerous business practice.


Unique Device Identification System

The FDA has established a unique device identification (UDI) requirement to recognize medical devices through their distribution and uses – implantable, life-supporting, and life-sustaining. Once implemented, all labels will include the UDI, which is readable by both humans and machines. Then, device labelers will submit specific information about each device to the FDA’s Global Unique Device Identification Database (GUDID). This is a crucial step toward increasing traceability, transparency, and accuracy across the entire healthcare supply chain.


UDI Tip Sheet


The UDI system also creates the opportunity for the medical device industry to align itself with a specific set of requirements and standards. With a common UDI system, healthcare providers can collect rich data sets and analyze them to get a better understanding of the effects of medical devices, pharmaceuticals, and supply choices regarding patient outcomes.

How an ERP Can Help

Enterprise resource planning (ERP) solutions are now playing a major role in the management, product manufacturing, and labeling that comply with regulatory requirements. Southeast Computer Solutions has worked with many clients to implement Sage Enterprise Management to meet the demands of this new UDI system. Easy to use and mobile friendly, Sage Enterprise Management adapts to your organizational and industrial requirements as well as to predefined user roles and preferences.

Regulatory Compliance

SCS’s UDI project management team designs and implements robust solutions to meet both system and regulatory requirements. The team will take all factors into consideration – including compliant barcodes ranging from GS1, HIBCC, or ICCBBA – and finishes projects in a timely, cost-effective manner.


Learn how Sage X3 and SCS can transform your organization’s complex manufacturing environment and manage FDA compliance and quality standards, and as well, how we can serve your unique device identification implementation. Contact Southeast Computer Solutions for more information.UDI eBook

About Southeast Computer Solutions

Southeast Computer Solutions is based in Miami, Florida, and has additional operations in Mexico. For over 30 years, we have positively impacted the success of small and mid-sized businesses with effective business management implementations that improve our clients’ operations. We listen, we are accessible, and we care. Learn more by visiting our website or calling 305-556-4697.


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