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- Affordable & cost effective compliance as a service.
- Experience and expertise in getting companies UDI Compliant
- Out of the box solution with simple, easy to use interface.
- Exceptional level of support and step by step practical advice
- Fully integrated validation check to facilitate data quality control.
- Regular updates to ensure new FDA legislation is met.
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WHAT IS UDI?
The FDA’s UDI – Unique Device Identification initiative was released In September 2013 and requires that all medical devices sold in the U.S adhere to global device identification standards of labelling. Medical device manufacturers must also provide a set of device attributes for inclusion into a Global Unique Device Identification Database (GUDID). If your company sells in the U.S, either directly or through distribution, then failure to comply with this rule within the required timeline will put your ability to continue to sell your products at risk.
The FDA ruling on Unique Device Identification (UDI), requires action in three main areas:
LABELLING & PACKAGING
One of the most important challenges of UDI compliance is labelling. Manufacturers must ensure device labels include not only device identifiers (DI), production identifiers (PI) and associated barcodes but also include 13 additional pieces of information. These requirements represent a major shift and require a labelling system that can capture these data sets accurately and efficiently and configure them to the appropriate label design.
That’s why kodit developed koditPaperFlex (kPF), a web-based label designer tool integrated into kUDID.
Manufacturers are responsible for submitting their medical device product information to the FDA database (GUDID) via the GUDID web interface or the HL7/SPL standard for bulk uploads. Kodit has developed a cloud based software kUDID that provides data validation and automatically produces SPL xml files so you don’t have to, leading to savings in time and money.
For more information about kUDID, click on learn more.
DIRECT MARKING (DM)
Direct Part Marking (DPM) is a UDI affixed permanently to devices that are intended to be used more than once and intended to be reprocessed before each use, rather than the packaging or label. The requirement applies to all device classes, except class I devices that bear a Universal Product Code (UPC). The compliance date is based on the device category.
Whether you’re looking for a long term solution to keep you compliant or just quick compliance we have solutions tailored to your needs.
UDI comes in two parts, master data management and labelling. Our UDI software offers compliance for both of these. We’ll guide you through the step by step process and assist you at every stage. We have a full knowledge of the regulations so if you choose we will take full control so you don’t need to worry about it.
If you only want quick compliance just send us your product data and you’ll be compliant within a week. We’ll negotiate the difficulties of setting up accounts with the FDA for you, quality control your data in line with UDI requirements and then submit it.
If you already have your data compliant and are now looking to do the same with your labels then we have just the tool. Our PaperFlex label designer allows you to create labels in the cloud and have the peace of mind that they’re GS1 compliant.
The process has already started and the 24th of September 2016 deadline has already passed for Class II.
frauen kennenlernen karlsruhe ABBREVIATION KEY: LS/LS = Life-supporting or life-sustaining ; I/LS/LS = Implantable, life-supporting or life sustaining
|Labels and packages of Class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.|
|Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.|
|A Class III device required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if this device is intended to be used more than once and intended to be reprocessed before each use.|
|A Class II device required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if this device is intended to be used more than once and intended to be reprocessed before each use|
|A Class I device (and devices that have not been classified into Class I, Class II, or Class III) that is required to be labelled with a UDI, must a bear a UDI as a permanent marking on the device itself if this device is intended to be used more than once and intended to be reprocessed before each use.|
Failure to comply with the ruling by the required dates will have a severe business impact as wrongly labelled products shipped to the US will not be accepted.
Yes, other countries will adopt the FDA ruling with local variants incorporated, large consumers like the NHS will be introducing UDI/GS1 compliance as a mandatory requirement in their supply chain. You may also produce products for other manufacturers or distributors who ship to the USA.[/toggle] [toggle title=”Can I avoid expensive consultancy services to become UDI compliant?”]
Yes, Kodit’s UDI Compliance SolutionTM provides fast and simple compliance for all classes of medical devices without the need for consultants and customised solutions.[/toggle] [toggle title=”Will I need to invest in new hardware to become UDI compliant?”]
No, the Kodit UDI solution is cloud based and provided to you as part of the solution, avoiding upfront investment you would otherwise need to make.[/toggle] [toggle title=”Will the Kodit solution feed the relevant product information to the FDA database?”]
Yes, when entering product information you will be populating the FDA database mandatory fields, when complete you are able to send your product information direct to the FDA via a HL7 data link, saving you time and additional effort.[/toggle] [toggle title=”Will the Kodit UDI solution cope with changes to the FDA ruling and variances introduced by other countries?”]
Yes, the Kodit UDI solution simplifies compliance, we also monitor these changes on your behalf and incorporate new requirements in future software releases so compliance is maintained, eliminating the need for you to spend time tracking these changes internally.[/toggle] [toggle title=”Can I avoid expensive consultancy services to become UDI compliant?”]
Yes, Kodit’s UDI Compliance Solution™ provides fast and simple compliance for all classes of medical devices without the need for consultants and customised solutions.[/toggle] [toggle title=”My Company is growing through acquisition, is the Kodit solution able to meet these requirements?”]
Yes, the Kodit software has been designed with built-in flexibility so the solution is equally applicable to SME’s through to global enterprises.[/toggle] [toggle title=”Can we transition to the new solution quickly?”]
Yes, the solution is straight forward and easy to use, the software has built-in User guides if required. If you need additional help to import existing product data or design your own label templates then we have a service that can do this for you.[/toggle] [toggle title=”Will the UDI solution remain compliant over time without additional charges for new software releases?”]
Yes, Kodit publish a future roadmap and you will receive automatic updates without additional charge[/toggle] [/accordion]
Contact us to learn more.