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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 […]


Unique Device Identification System (UDI)

The FDA established the Unique Identification System (UDI) to identify medical devices sold in the US from the point of manufacturing and distribution all the way to patient use. The UDI final rule requires device labelers to: Include a UDI on device labels and packages, except where the rule provides for an exception or alternative. […]


Labeling Regulations by Industry

Managing the requirements and following the guidelines when it comes to regulatory compliance labeling can be a challenge. Especially for organizations in the chemical, medical, and food & beverage industries. It’s become a higher priority for companies with adherence to strict and evolving policies that have placed additional  demands for compliance labeling. Chemicals: Global harmonized […]


UDI Labeling in 2018

With 2017 coming to an end, it is a good time to preview what is upcoming in 2018 for medical device labeling in the US. The Unique Device Identification Rule has been a popular topic over the past two years and it has achieved many milestones, requiring medical device manufacturers to follow labeling on Class […]


EU MDR Compliance Labeling

The European Commission legislation is introducing new compliance requirements on medical devices and creating completely new medical device regulations (MDR). Following in the footsteps of the Food and Drug administration of the US, EU has decided to adopt the Unique Device Identifier (UDI) for all medical devices and In Vitro Diagnostics (IVDR). This will be […]


Why UDI & MDR?

In the barcode industry, there is considerable dialogue about (UDI) Unique Device Identification and (MDR) –Medical Device Regulation. We read and hear all about the initiatives and the deadlines, but why are these compliance requirements so important….   These compliance regulations provide for more accurate reporting, content review and the ability to report on device […]