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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Slide1

The NiceLabel Guide to UDI compliance

Not ready for September 24? You can still make it.
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.

Slide3

More about UDI and related topics

NiceLabel Medical Devices Case Study

Case Study:

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.

Download case study

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

White paper:

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.

Download white paper

Dental device manufacturing case study

Case Study:

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. 

Read more

How to choose a UDI Issuing Agenncy

Blog post:

How to choose a UDI Issuing Agency

With the advent of compulsory Unique Device Identification (UDI) for medical device labels, companies in the sector must select a device identifier issuing agency. The US Food and Drug Administration (FDA) has accredited three agencies so far, from which medical device labelers can select one or two.

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UDI Conference report

Blog post:

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.

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UDI Conference report

Blog post:

Conference Report: A sense of PANIC!

Reports from the UDI conference in April in Baltimore and the Medical Device Packaging conference in April in Alexandria. NiceLabel participated in a couple of medical device industry conferences which were both eye-opening in different ways. The looming issue of UDI compliance was at the heart of both conferences, though they took contrasting approaches.

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