UDI compliance date extension

What you need to know about the UDI compliance date extension

Susan Gosnell Life Sciences 2 Comments

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension letter to device labelers, extending the UDI compliance date to September 24, 2018 for certain Class II devices. The devices impacted by the UDI compliance date extension are classified as: Convenience kits Repackaged single-use devices The letter also clarified that the compliance date for biologic and …

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Smart manufacturing at the center of the fourth industrial revolution

Ken Moir Industry news 1 Comment

In the fourth industrial revolution (also known as Industry 4.0), smart factories will be able to reconfigure themselves in response to changes in demand; industrial scale USB ports will control thousands of sensors and computer-enabled devices in a plant, enabling them to change to different tasks and modules in an instant. This is the vision of Professor Detlef Zühlke at …

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Software as glue – connecting smart technology with manufacturing

Ken Moir Industry news Leave a Comment

“There’s a new era of manufacturing,” General Electric’s President of Transportation Jamie Miller told an audience of manufacturers at a major industry conference in Chicago in May. “The Industrial Internet isn’t just a probability, it’s really here today,” said Miller at MESA 2016. Additive 3D printing, lean and virtual manufacturing, sensor-based technologies and supply chain optimization are revolutionizing GE’s operations, …

 

Getting control of labeling

Lee Patty Industry news Leave a Comment

It goes without saying that once you design a label, it needs to be printed.  Many companies are experts when it comes to the basics of label design. The part has some businesses scratching their heads is how to best “manage” all of those labels and the “printing process” that goes along with them. Many companies use “hard coded” or …

System Modernization Offers Manufacturers an Opportunity for Process Improvement

Ken Moir Industry news Leave a Comment

Legacy system modernization is a big trend in the manufacturing industry. Manufacturers are beginning to realize their fragmented labeling processes and IT systems leave them ill-equipped to compete in today’s dynamic, global environment. Many are now planning big changes to modernize their labeling systems and processes in order to achieve greater agility. When manufacturing companies undergo modernization efforts they tend to …

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Rush of Interest in Labeling Solutions

Ken Moir Industry news Leave a Comment

Addressing new legislation and regulations, improved risk management, greater supply chain management visibility and quality control, an ability to standardize and centralize…the list of advantages of a next generation labeling solution grows by the month. Sure enough, NiceLabel’s stand at June’s SAPinsider conference in Vienna* was ‘mobbed’. The interest came not only from supply chain professionals but from IT people …

Medical device

European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations

Susan Gosnell Life Sciences Leave a Comment

The medical device directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision has the following objectives: To ensure a consistently high level of health and safety protection for EU citizens using these products To maintain the free and fair trade of the products throughout the EU To adapt legislation to the …

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Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Life Sciences Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …

Common UDI label mistake: The barcode prints over the edge of the label

UDI labeling: common mistakes and best practices

Marko Vrbnjak Life Sciences Leave a Comment

There’s no doubt that UDI is a hot topic among medical device manufacturers. They are currently under pressure to comply with the FDA’s UDI requirements. Europe plans to introduce similar rules that companies will need to adhere to in the next three to four years. Other countries like Brazil, Turkey and China are introducing their own rules. It’s clear that …

Who bears responsibility for submitting UDI data to the GUDID

Who bears responsibility for submitting UDI data to the GUDID?

Reed Tech Life Sciences Leave a Comment

The FDA has specified in its Final Rule on Unique Device Identification (UDI) that medical device labelers marketing their products in the United States are required to submit data records to its Global Unique Device Identifier Database (GUDID, pronounced “Good-ID”). Which company qualifies as the device labeler? The next question to ask is which company (or companies) involved in bringing …