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Navigating global UDI

We have spoken frequently about the importance of Unique Device Identification (UDI) systems and their ability to improve traceability of medical devices throughout the supply chain to ensure patient safety. Our partners at Loftware share more about navigating global UDI systems and how they are “an integral part of streamlining regulatory processes.” As mentioned above, […]


Global UDI Compliance

The Universal Device Identification (UDI) system was developed by the U.S, Food and Drug Administration (FDA) as global UDI compliance to protect patients and clinicians by improving traceability of medical devices through a common and shared system. It has and continues to fulfill its role in safety and traceability tenfold and medical device software has […]


Medical device labeling matters

Accuracy in healthcare is essential, if not expected because one incorrect piece of information can result in irreparable damage to a patient. Medical devices “can be complex, but clear and accurate labeling ensures that the right information, directions, warnings, and risks are available to the healthcare professionals who use them.” Loftware shares why medical device […]


Warehousing and Compliance

When we talk about compliance we often look at labeling regulations that are required to keep businesses from being fined, but warehousing and compliance entail so much more. Legislative standards for traceability, worker health and safety, and warehouse quality and safety standards are all part of warehouse compliance standards that warehouses look to meet and […]


Pilot Program Recycles 40,000 Pounds of Used Medical Devices

As technology advances, companies often look to create materials that can be reused or at the least, recycled. Medical Devices are an industry that creates a large amount of waste. In response to this “medical technology company BD (Becton, Dickinson and Company), and Casella Waste Systems, a solid waste, recycling and resource management services company, […]


The intricacies of FDA regulations

The Federal Drug Administration (FDA) provides regulation for food, drugs, medical devices, radiation-emitting products, vaccines, animal and veterinary products, cosmetics, and tobacco products.  Just in the radiation-emitting products category alone, they are responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. That is a lot of oversight! The […]


Labeling automation reduces templates by 40%

A global leader in medical devices found that automating their labeling process could reduce the number of label templates by 40%.  This is an astounding number considering the medical industry is one of the most heavily regulated environments. The ability to move from manual processes and inputs to a fully automated solution can only result […]


Spectrum for the medical device industry

“Loftware Spectrum® for Medical Device redefines how enterprises create, manage and print labels, enabling medical device enterprises to meet rigorous regulatory requirements.” Whether your company invests in a cloud or on-premise version, Spectrum for Medical Device provides “accuracy, consistency, and compliance.” When deciding whether Spectrum is the right solution for your medical device needs, here are […]


New device to analyze health data

The benefits of an Apple® Watch without the watch? “Researchers at the University of Chicago’s Pritzker School of Molecular Engineering have developed a flexible, stretchable computing chip that processes information by mimicking the human brain.” This technology is centered around the popular trend of wearable technology and ever-growing artificial intelligence.  The hope is that this […]


SHL Medical to Build New Plant in South Carolina

Many manufacturers work on a global scale, having plants located in numerous countries can make producing the same products, meeting the same regulations, and achieving the same quality standards a challenge. An enterprise labeling solution and a fully integrated system can help make this a little easier. SLH Medical’s new manufacturing plant in South Carolina […]