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
Given the intricacies and complexities of the FDA’s UDI compliance regulations, we 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.
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 compliance. And, 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:
- 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.
As a Kodit master licensee, we are positioned to offer the Kodit solution directly to end-user device manufacturers or to UDI consultants and VARs on a resale or referral basis. UDI compliance is an ongoing process and we understand the importance of spreading the financial burden of becoming compliant over the course of that process either through traditional lease financing or a SaaS arrangement.
Whether a given solution begins with Kodit or not, our services and product offerings don’t stop there. We know UDI compliance better than most and are just a phone call or short email away from providing you with the assistance you need.
Our sister company, Vantage ID Applications, Inc. is celebrating its 24th anniversary this year. Through Vantage ID we offer over two decades of barcode labeling expertise with the products and supplies you’ll need to comply and remain compliant under FDA and NHS UDI mandates. Experts in harsh label environments, we’ll work with you to determine the right label/ribbon combinations to ensure your UDI labels stay readable over their lifetime, as mandated. Our selection of barcode label printers and scanners, barcode verifiers, and label applicators is vast. We work with TEKLYNX, NiceLabel and Seagull Scientific/Bartender to make label design and printing easy, efficient and cost-effective for any size business, from SMB’s to companies requiring multi-location, enterprise printing solutions.
UDICS provides the best combination of UDI compliance knowledge and barcode labeling expertise in the marketplace.