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.
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.
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.
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.
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.