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.

Whether you need pre-printed UDI labels or a cloud-based UDI labeling software solution, we help you choose, implement, and support the right approach for your operation.

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: Low to moderate volumes, stable device data, or limited IT resources.

We design and produce compliant UDI labels using your approved device data and GS1 formats.

Benefits:

• Fast implementation

• No software required

• High-quality, validated materials

• Ideal for smaller device portfolios

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.

• 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.