Compliant labeling that transforms your business

Medical device manufacturers are facing increasing regulatory pressure. The FDA's UDI requirements are well underway in the U.S. and the European Union Medical Device Regulation (EU MDR) is quickly taking shape with similar directives.

NiceLabel offers a next generation label management system that enables UDI compliant labeling while increasing agility and reducing operational costs.

Learn how modern label management helps medical device manufacturers compete in a challenging marketplace.

Download our white paper

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Life science companies rely on NiceLabel

  • Lina
  • Ultradent
  • Krka
  • Sanofi
  • Arla Foods
  • Abbott logo
  • Sonova
  • Nuvasive
  • Sorin

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Complimentary webinar

Label Compliance and the New European Medical Device Regulations (MDR)

Learn what medical device manufacturers need to do to prepare for compliance, the benefits of implementing a label management system and how label verification and print quality inspection aid compliance.

When: October 11th 2017

Recorded webinar available

View now

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Future-proof technology built for Life Sciences

NiceLabel’s label management system, LMS Enterprise, enables you to automate label printing by implementing a standardized integration with ERP, MES and other business systems at each site. By centralizing master data and establishing a single source of truth, you can eliminate manual data entry errors, mislabeling and associated costs.

Integrate label printing with MES and ERP

LMS Enterprise seamlessly integrates with MES, ERP and PLM systems. This ensures your products are always labeled with the right master data coming directly from a central database. Company-specific business rules can be applied so that printing specifics are handled without costly changes to the ERP or MES system.

A document management system that streamlines compliance with regulatory requirements

LMS Enterprise includes a document management system (DMS) that was built for regulatory labeling. It’s a centralized digital label catalogue that controls and streamlines label lifecycle management by providing role-based access, document versioning, configurable approval workflows, and electronic records and electronic signatures (ERES) which are necessary to conform to FDA and EU regulations. A graphical “label comparison” tool helps consolidate label template variations and provides added quality assurance.

Electronic records and audit trails that exceed life science regulation requirements

LMS Enterprise provides a comprehensive set of audit trails, including full traceability and visualization of every printed label. Traceability extends beyond printing to include every change request and every system event, including user, location and timestamp information. Additionally, electronic PDF documents reflecting physically printed labels, can be natively generated for submission to 3rd party content management or PLM solutions.

Change and transport system built for life sciences

LMS Enterprise fits seamlessly into the typical, multi-tier IT landscape of medical device manufacturers and includes a change and transport system for controlled and streamlined promotion of changes through different environments like development, quality assurance and production.

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Case study

LiNA Medical reduces operating costs as part of UDI compliance

Download the Case Study

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Transform your labeling processes to accelerate growth

By modernizing your processes with the NiceLabel Label Management System (LMS Enterprise), you will:

  • Reduce operating costs: less quarantine, less rework, less recalls and happier customers.
  • Achieve quicker time-to-market: business users are empowered to respond to controlled label change requests without IT assistance.
  • Increase productivity & reliability: remove manual tasks, streamline label lifecycle management and increase transparency of your labeling process in order to create a more effective and robust supply chain.

Rely on a professional services group with domain expertise

NiceLabel’s professional services group (PSG) can configure and deploy the NiceLabel label management system to ensure that the system is implemented according to best practices. The PSG team can provide IQ, OQ and PQ validation packages and services to help meet your documentation needs and regulatory requirements.

Learn more about NiceLabel products

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More medical device resources

Case Study

NiceLabel Medical Devices 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

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

Download white paper

Case Study

Dental device manufacturing case study

Global dental device manufacturer achieves compliant UDI labeling and Oracle integration

Download case study

Blog post

UDI Compliance Date Extension

Validation of increasing importance for life sciences companies

Read more

Blog post

How to choose a UDI Issuing Agenncy

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

Read more

Blog post

European medical device directives

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

Read more

Blog post

The EU MDR and IVDR have been approved

The EU MDR and IVDR have been approved. So, what’s next?

Read more