FDA Requirements a Headache


AbeTech Makes UDI Easy to Navigate
The FDA began rolling out a system in 2013, called Unique Device Identification (UDI). Except for some specific exceptions, the system requires a UDI on all medical device labels and packages.
A UDI is a numeric or alphanumeric code unique to each product. Medical devices require a UDI that’s fully legible – easy to read both by machines and by people. Device labelers must submit designated information about each device to the FDA’s Global Unique Device Identification Database (GUDID); ensuring every product is accounted for.
The UDI system is intended to help identify a diverse range of medical devices throughout their lifecycle; aiming to protect patient safety, encourage and monitor innovation, and increase device accountability.
If your business has been effected by UDI requirements, you’re probably wondering how to comply with FDA requirements, while maintaining flawless workflow and staying within budget.
Great Technology + Awesome Professionals = Your Success
At AbeTech, our specialty is helping you find easy, effective solutions that make major changes like the FDA’s UDI requirements a snap.
When you work with AbeTech, you get:

  • Industry experts at your side so you don’t have to worry
  • The best printing and labeling option customized for your business
  • An effective system rolled out across your business without interrupting productivity
  • UDI guidelines and FDA compliance made easy

We know how important it is for your business to find a printing and labeling option that’s effective, efficient, and affordable. We also know you don’t have time to waste muddling through complex requirements or sifting through options.

That’s why, here at AbeTech, we bring you industry experts with your success at heart. We can’t wait to meet you, discuss your business, and find the best, FDA-compliant option for your company. After all, AbeTech is all about making your business bigger and better everyday.

Now’s Your Opportunity. Let’s Make Your UDI Experience Easy and Hassle-Free

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