Going beyond UDI compliance - implementation of dedicated labeling system

"Our goal is to have a zero-error environment, and NiceLabel’s label management system plays a big role in that. We can already see the positive impact the system has had on our productivity and transparency, and we expect that those benefits will only increase over time" – appraises Michał Mydlikowski, Logistics Manager at LiNA Medical

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"Our goal is to have a zero-error environment, and NiceLabel’s label management system plays a big role in that. We can already see the positive impact the system has had on our productivity and transparency, and we expect that those benefits will only increase over time" – appraises Michał Mydlikowski, Logistics Manager at LiNA Medical

LiNA Medical is a privately held Danish corporation operating in the field of minimally invasive gynecology. Through close interaction with physicians they develop innovative products, specifically designed for gynecology, based on their vision of improving quality of life for women all over the world undergoing treatments for gynecological conditions. The company distributes products globally. LiNA’s supply chain, quality, manufacturing and engineering operations are housed in Poland, while research and development is in Denmark.

The company must comply with UDI guidelines when it ships products to the United States.

UDI (Unique Device Identification) is a system of FDA unique products identifiers which was designed to track medical devices throughout the entire distribution and use cycle.

Existing environment

LiNA Medical had a homegrown standalone labeling system that wasn’t integrated with its ERP system. Labels were created in the labeling system, and production work orders came from the ERP system.

The company markets and sells Class I and Class II medical devices. Some products have three levels of packaging: individual pieces, inner box and outer box. Others have only one or two levels of packaging. LiNA ships product all over the world, so labels needed to be printed in multiple languages.

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Benefits of implementation:

  • Full tracking and control of labeling process
  • Significant reduction of errors at products labeling
  • Costs and labor hours reducing
  • Reduced shipping delays
  • Increase in production efficiency