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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, […]


Discussion with Pharma Experts

Our Loftware partners conducted a recorded webinar discussion with pharma experts about how regulatory labeling challenges impact the global pharmaceutical industry. During this webinar, the conversation covered: Standardizing global labeling operations Integrating labeling with existing business applications Increasing supply chain efficiency and agility The opportunity to hear from industry experts with firsthand experience working within […]


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 […]


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 […]


Powerful labeling tools for complex labels

As if compliance and regulatory requirements weren’t complicated enough when addressing labeling solutions for the pharmaceutical industry, add counterfeiting, tampering, and 21 CFR Part 11 to the mix. Now you have an intricate process that requires you to have a reliable, trustworthy solution that you can depend on to produce the correct output. BarTender provides […]


The first Cloud-based RFID encoding and logging system

“Solution enables producers of medical devices, pharmaceuticals, and luxury goods to meet stringent traceability requirements.” There is an increased requirement for medical devices to include a unique device identification number (UDI) to identify devices implanted in the body.  The effort launched between Loftware’s NiceLabel Cloud software and SATO, a pioneer in auto-ID and labeling solutions, […]


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 […]


Doctor indicted for adulterating medical devices

  A doctor in Raleigh, North Carolina was indicted for the extreme misuse of a medical device in addition to Medicare fraud and making and using materially false Healthcare Documents.  Many of the patients were misled by thinking the medical device, was sterile and was used for the first time during their surgery. A balloon […]


The engineer behind the first CT scan

When we think about medical devices, we may not take much time to consider when they were first invented. It may be hard to imagine that October 1, 1971, was 50 years ago but many of today’s most used medical devices were invented in the last 100 years including the first computed tomography image or […]


Device taps brain waves to help with communication

Communication and the ability to communicate are often taken for granted, but not so for a person that has been without this ability.  “In a medical first, researchers harnessed the brain waves of a paralyzed man unable to speak—and turned what he intended to say into sentences on a computer screen.” While it will take […]