COMPLYING WITH FDA 21 CFR 821

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Given the intricacies and complexities of the FDA’s UDI compliance regulations, VantageID has formed UDI Compliance Solutions, LLC to help make the path to compliance easier and faster! We offer a cost-effective, comprehensive solution that will facilitate compliance from master data collection and management to GUDID submissions to label design, formatting, printing, verification and application.

 

In our The FDA’s UDI Compliance Mandate in Plain English series, we have addressed some of the implications of the FDA’s UDI compliance mandate, including the basic challenges faced by medical device manufacturers in becoming UDI compliant. Please click any of the links below to read any or all of the installments in that series:

The FDA’s UDI Compliance Mandate in Plain English – Introduction
The FDA’s UDI Compliance Mandate in Plain English – Who Benefits?
The FDA’s UDI Compliance Mandate in Plain English – How Long?
The FDA’s UDI Compliance Mandate in Plain English – The Label

RECOMMENDED COMPONENTS FOR YOUR UDI COMPLIANCE SOLUTION

Solutions are entirely dependent on our customers’ requirements. Each solution is comprised of state-of-the-art product components, including hardware and accessories, software, and supplies that can help you comply with FDA labeling requirements.  Following are samples of the various components that could be combined to fulfill the requirements of your enterprise:

SOFTWARE

Depending on the number of devices that require a UDI, our total solution may begin with the use of Kodit, which offers the fastest path to UDI complianceAnd, because it is cloud-based, this unique software application enables our users to achieve regulatory compliance with FDA and NHS mandated requirements globally! 

In a nutshell, Kodit is:

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  • A cloud-based, turnkey, off-the-shelf, ready-to-go solution that requires no customization or costly consulting.
  • Allows users to compile and upload data from disparate systems.
  • Uses built-in business logics to review, approve and make HL7 electronic submissions to GUDID with a dashboard to show progress every step of the way!
  • Prior-to-submission testing reduces or eliminates rejections and costly back-and-forth time with regulatory agencies.
  • Interfaces with any PLM, ERP or label formatting system.
  • Becomes a “single source of truth“, allowing admin users to control granular user access with full audit trails for every action and submission.
  • Makes ongoing compliance easier by incorporating new attributes stemming from ongoing FDA and NHS updates.
  • Kodit was developed by Kodit UDI Ltd, a 1WorldSync Solutions Partner and GS1 certified solutions provider based in the UK.

Kodit is available either as a standard software license purchase/lease or SaaS contract.

CodesoftLABEL FORMATTING

VantageID partners with the industry’s leading label design and printing software companies. Whether you are a new start-up, an established brand, or an enterprise level entity seeking the best ways to increase efficiency in everything you do, having the right labeling solutions to suit your specific stage of development is the most cost-effective way to make sure UDI labels are formatted and designed with all of the information required by the FDA.

 

SUPPLIES

Zebra Labels & Tags PicWIDE SELECTION OF LABEL AND TAG STOCK

With over 100 paper and synthetic label and tag materials, our selection of Zebra standard and premium paper and synthetic substrates will help ensure that your UDI labels stay on your medical devices over there lifetime, as required by the FDA.

Ribbon PhotoTHE WRONG LABEL STOCK AND RIBBON COMBINATION CAN SPELL DISASTER!

Ribbons are formulated with different inks and ink combinations, each of which is better suited for one application over another. If you don’t match the right ribbon formulation to the label material you need, your UDI labels are like to fail.

HARDWARE

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INDUSTRIAL PRINTER

110Xi4

Zebra’s rugged XI4 Series of industrial label printers boosts productivity and delivers superior print quality and reliability under the most demanding conditions.

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INDUSTRIAL PRINTER

ZT400

Zebra’s ZT Series printers have been engineered and designed for reliable, affordable printing.  Crisp, clean text and barcodes—even on narrow media.

zebra-gx-and-zd500

DESKTOP PRINTER

GX430T

Zebra’s compact, feature-packed G-Series™, GX™and ZD500™ printers offer four connectivity options and high-resolution print quality at the fastest print speeds.

See our complete selection of Barcode Printers

Barcode Scannerzebra-cs4070-hc-scanner

Zebra CS4070-HC

The disinfectant-ready CS4070-HC puts wireless, enterprise-class barcode capture in the hands of every care giver within the four walls of a hospital for scanning UDI med device labels.

Wearable Barcode Scannerzebra-rs6000-ring-scanner

RS6000 

Wearable scanning devices allow your care givers to use both hands in providing care at all times.

See our selection of Barcode Scanners

Zebra Mobile MC40

Mobile Computer

MC40-HC Touch Computer

The fully-featured, pocket-sized MC40-HC has been engineered to rival the design of today’s coolest consumer mobile devices, including smartphones.  Your care givers and hospital staff will instantly feel comfortable with the all-touch MC40-HC and will know how to interact with the device, virtually eliminating training. Scanning UDI labels has never been easier.

See our selection of Mobile Computers

 

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