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.

UDI compliance

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The NiceLabel Guide to UDI compliance

Read our UDI compliance guide to understand the requirements, how to prepare and ways to steamline implementation.

Download the Guide to UDI compliance

Slide2

Benefits of the NiceLabel label lifecycle management solution

Preparing for FDA 21 CFR Part 11 and EU GMP Annex 11

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.

Preparing for FDA 21 CFR Part 11 and EU GMP Annex 11

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.

Preparing for FDA 21 CFR Part 11 and EU GMP Annex 11

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.

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More about UDI and related topics

Case Study

Medical device company achieves global UDI compliance while improving accuracy and reducing costs

Download case study

White paper

Preparing for FDA 21 CFR Part 11 and EU GMP Annex 11

Download white paper

Dental device manufacturing case study

Case Study

Global dental device manufacturer achieves compliant UDI labeling and Oracle integration

Read more

Blog post

Validation of increasing importance for life sciences companies

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Blog post

The Class II UDI deadline is past. Enterprise labeling is the future.

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Blog post

How a small-medium sized medical device company responded to the new regulations

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