Medical device manufacturer’s have to constantly comply with the ever changing demands and regulations in their industry. On top of that, keep their eye closely on lowering cost and increasing profits as they remain competitive. These challenges emphasize the requirement of a system that will allow them to effectively run their business and roll with the changes.
One of the recent requirements is the Unique Device Identification (UDI)which allows the FDA to track medical devices from sale to user and beyond. This specifically for implantable, life-supporting, and life-sustaining devices. Humans and machines alike can read the UDI on the device label. The device details will be provided to the FDA’s Global Unique Device Identification Database (GUDID) via a device labeler. A big accomplishment to support transparency, accuracy and traceability for the whole health case system.
This allows the creation of UDI standards and requirements for the medical device industry, thus supplying healthcare professionals with a deep set of data to leverage.. This will provide analytics to identify patterns and results to improve the use of pharmaceuticals, medical devices and potential improvement in medical procedures.
Enterprise resource planning (ERP) solutions have been instrumental for many medical device manufacturers managing the entire process from manufacturing and regulatory labeling to cost and profits. We at Southeast Computer Solutions (SCS) have helped many clients 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.
The team at SCS can manage and implement your UDI solution and to comply with the FDAthe regulatory requirements. The team will take all factors into consideration – including compliant barcodes ranging from GS1, HIBCC, or ICCBBA – and finishe your project 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. Contact Southeast Computer Systems for more information.
Since 1985, Southeast Computer Solutions has been a top Sage Authorized Business Partner helping small to medium sized businesses get the right software to run their operations. With over 600 Sage software installations and implementations across the United States and in Latin America, Southeast Computer Solutions is the largest Sage business partner in south Florida. We pride ourselves on technical expertise, real-world business experience and spirit of true partnership with our clients. Headquartered in Miami, Florida, Southeast Computer Solutions serves the small to medium sized businesses in a wide range of industries from West Palm Beach, Pompano Beach, Coral Springs, Sunrise, Fort Lauderdale, Hollywood, Pembroke Pines, Hialeah, Miami, Doral, Coral Gables and other locations. We also serve the international community including Mexico, Caribbean Islands, Central America and South America.
Another version of this blog was previously posted on January 19, 2016. Unique Device Identifiers and FDA Compliance http://blog.southeastcomputers.com/unique-device-identifiers-and-fda-compliance
Photo courtesy of freedigitalphotos.net by hywards