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Industries – Medical Devices

Quality Medical Device Labels that Meet FDA Compliance

The Food and Drug Administration (FDA) has a series of specific requirements when it comes to medical device labeling, but those requirements don’t have to constrain you. Imprint Enterprises is an experienced partner that can help your company enjoy the benefits of a high quality label that meets FDA requirements. 

The FDA requirements allow hospitals and health care providers to pinpoint what equipment has been placed in use for traceability purposes. We help manufacturers meet these requirements so that their products can more easily help with patient care.

Meeting UDI requirements

Unique Device Identifier (UDI) labels help manufacturers, hospitals, and healthcare providers to serialize every medical device in use. UDIs are used to quickly gain access to key traceability information when the need arises. The ability to quickly scan your labels means a reduction in medical errors, improving patient safety.

UDI-compliant labels help in traceability and quality control. They provide information on: 

  • Where a device originated 
  • Who made a device
  • The lot number for the specific device
  • The age of a device

All of this information can be extremely useful in the course of patient care. The UDI contains a PI, or production identifier and a DI, or device identifier. Both can be useful in the course of tracing the product to a manufacturer. 

All UDI labels require verification with the Food and Drug Administration. Data collected for these devices must be collected and sent to the Global Unique Identifier Database. Part of the verification process is to ensure that your barcodes are readable. Imprint Enterprises can help you make informed decisions as you create FDI compliant UDIs for devices. Compliance can be met through a product label or an RFID chip. 

At Imprint Enterprises we’ve helped medical device companies meet UDI requirements with quality, durable labels that are easy to scan and read. If your product is electronic, we have the technology to help you meet UL/CSA requirements as well. You invested time and effort in developing your medical device. Let us help you with all of the necessary compliance and logistics labeling. 

A Powerful Partner in Technology

A key part of the FDA requirements is that your barcodes must be readable – and meeting that requirement may take a software and technology upgrade. We have the necessary tools and expertise to get the most out of your UDI labels. 

BarTender – We offer the latest versions of BarTender software, and the necessary guidance to get the most from it. BarTender can help you maintain control of the label’s chain of custody which is critical for any legal implications. When you produce a label, you receive FDA approval and it can be placed. When the FDA changes requirements, you need to modify that label. BarTender helps you document this process to make your compliance more transparent. 

Industrial Barcode Printers – We also offer the latest in industrial printer technology so that you can make sure that your labels meet requirements the first time. Our printing solutions offer you high-volume printing options for a fast-paced environment.

Barcode Verifiers – Make sure your barcodes can be read correctly before your product is sent out into the supply chain. They can help you measure your barcodes against industry standards. Imprint Enterprises sells high quality barcode verifiers from Cognex, Honeywell and LVS.

Durable Label Materials – When you place UDI labels on medical devices, those labels must be able to withstand the sterilization process. We have the necessary durable labeling materials that are built to last. 

RFID Technology – Another option for UDI compliant labeling is in RFID technology. We offer all the necessary hardware and software to convert to an RFID labeling system.

Let Us Help with Your Medical Device Lab

When it comes to creating quality medical device labels, Imprint Enterprises can help you every step of the way. We have the product and expertise to make sure you get this crucial step right, the first time. 

If you have any questions, or would like to talk about your next labeling project, contact us today!

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