Meeting UDI requirements is complex—especially when labeling systems are manual, disconnected, or difficult to validate. GMP Labeling provides UDI compliant label solutions that help medical device manufacturers meet FDA and global UDI regulations with confidence.

Moving from static label templates to an integrated UDI labeling system reduces the burden on your Quality and Regulatory teams. Our partnership with industry leaders like Loftware allows us to deliver a validated labeling ecosystem.

• 21 CFR Part 11 & Annex 11 Compliance: Maintain a complete audit trail with electronic signatures, version history, and secure user access controls.
  
  

• Centralized Label Management: Control all UDI label templates from a single location, whether you are printing in-house or sharing designs with global contract manufacturers.
  
  

• Dynamic Data Integration: Eliminate manual entry. Pull UDI data directly from your ERP, PLM, or QMS to ensure the barcode matches your production record.
  
  

• Validated Workflows: Our software supports your validation requirements (IQ/OQ/PQ) with standardized processes and documented revision control.

Unique Device Identifiers (UDI) labels are used to identify a specific medical device throughout the global supply chain. UDI systems are growing worldwide, from the USA’s FDA UDI, Europe’s EU MDR, India’s CDSCO, and China’s NMPA. These regulatory requirements mandate that medical devices are labeled with unique identifiers, allowing for better traceability throughout the entire device lifecycle - from manufacturing to patient use. The goal is to enhance patient safety by ensuring that accurate, up-to-date information is available at every stage.

However, differing standards create complexity for global manufacturers, requiring companies to implement robust, nimble, and accurate systems to manage UDI labels. Manufacturers must steer through varying timelines, requirements, and submission processes across jurisdictions, making UDI label management a critical focus.

UDI labeling is more than a regulatory checkbox—it is a foundation for traceability, recall readiness, and patient safety. Manual or error-prone labeling increases the risk of:

• Incorrect device identification

• Regulatory findings or warning letters

• Costly recalls and rework

• Data inconsistencies across systems

GMP Labeling’s UDI solutions reduce risk, improve data accuracy, and support audit readiness across your labeling process.

Best for: Growing manufacturers, frequent data changes, multiple SKUs, or global labeling requirements.

Our software-driven UDI solution connects your device data directly to approved label templates—ensuring every UDI label is accurate, controlled, and traceable.

Key capabilities:

• Centralized device data management

• Automated UDI label generation

• Version control & audit trails

• User access controls

• Cloud-based scalability

• Validation-ready workflows

This approach reduces manual errors, supports regulatory audits, and scales with your business.

We don’t just sell labels or software—we act as your UDI systems partner.

1. Assess your current labeling and compliance risks

2. Design a compliant labeling workflow

3. Select the right software or pre-print solution

4. Implement & validate your labeling system

5. Support & scale as your product portfolio grows

We provide the full solution: software, labels, printers, ribbons, and integration services.

Software is the brain of your labeling operation, but it requires the right hardware and materials to perform in medical environments. GMP Labeling provides the full stack:

• UDI-Ready Printers: High-resolution thermal transfer printers optimized for small-font UDI compliance.
  
  

• Validated Materials: Synthetic labels that withstand sterilization (Autoclave, EtO, Gamma) and harsh clinical handling.
  
  

• System Integration: Expertise in connecting your labeling software to the rest of your operating system.

• Reduce compliance risk and audit findings
• Improve data accuracy across labeling systems
• Increase speed to market for new devices
• Lower total cost by eliminating manual errors
• Support global expansion with scalable UDI workflows

As a Strategic Partner with Loftware, we have built our Label Integration Solutions using Loftware's worldclass label printing software.

Our solution can be utilized with any Loftware license tier. Learn more about our Loftware products here.