UDI compliance with NiceLabel
Medical device companies are facing increasing pressure from government regulations. The FDA's UDI requirements are imminent in the U.S., but in the very near future the EU and other countries will enforce similar requirements, resulting in a stream of changes to labeling in the coming years.
NiceLabel offers a next generation label lifecycle management solution that enables UDI compliant labeling while delivering process improvements and agility that drive down labeling costs. With NiceLabel, business users can design, review, approve and control label data from an HTML5 based Web application.
Benefits of the NiceLabel label lifecycle management solution
Streamlined label change management
NiceLabel lets business users harness the power of centralized database storage to find, visually compare and modify label templates. Browser based access improves workflows and collaboration to deploy approved label changes globally in a matter of hours instead of months.
Fast and flexible setup
Download the software today, and you can be printing UDI compliant labels tomorrow.
Integrating with business systems for single source of truth label data is easy! Pre-built connectors are available for SAP and Oracle while HTTP, Web services and database connections integrate with other systems. Gain confidence in data accuracy while eliminating time consuming manual data entry.
Prepared for an audit
With NiceLabel, you don't need to store a copy of all labels and changes in separate files or paper archives. All label transactions, including changes are automatically sorted and ready for inspection if the FDA happens to drop by.
More about UDI and related topics
Medical device company achieves global UDI compliance while improving accuracy and reducing costs
This medical devices company was facing challenges with facilitating foreign language translation, streamlining the label approval process, achieving compliance with global regulations and reducing label errors.
Preparing for FDA 21 CFR Part 11 and EU GMP Annex 11
This white paper examines the FDA and EU regulatory standards and outlines how NiceLabel solutions ensure proper label life cycle compliance. You will learn how NiceLabel integrates the labeling required for life sciences regulations with customers’ existing workflows and business information systems including Oracle, SAP, or another ERP systems.
Global dental device manufacturer achieves compliant UDI labeling and Oracle integration
The dental product manufacturer needed to comply with multiple regulations including FDA 21 CFR Part 11, Part 820 and UDI as well as ISO 9001 and 9002 without adding complexity to print processes.
The Class II UDI deadline is past. Enterprise labeling is the future.
Last month, the UDI deadline for Class II devices came and went and many medical device manufacturers breathed a collective sigh of relief. Others are taking advantage of the extension for convenience kits and repackaged single-use devices, or still working to get their labeling and data organized for GUDID submission.
How a small-medium sized medical device company responded to the new regulations
The company noted that compliance has allowed new strategic decisions to be made, has potentially reduced the number of competitors, provided opportunities for market expansion and enhanced patient safety and product performance.
What you need to know about the UDI compliance date extension
On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension letter to device labelers, extending the UDI compliance date to September 24, 2018 for certain Class II devices.The devices impacted by the UDI compliance date extension are classified as Convenience kits and Repackaged single-use devices.