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.
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. Net at Work has worked with many clients to implement Sage X3 to meet the demands of this new UDI system. Easy-to-use and mobile-friendly, Sage X3 adapts to your organizational and industrial requirements as well as to predefined user roles and preferences.
Regulatory Compliance
Net at Work’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 Net at Work 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 Net at Work for more information.
