Medical Device Labeling Solutions
Reliable, Compliant, and Flexible Label Printing for Medical Devices
Medical device manufacturers face complex and evolving labeling requirements. From FDA Unique Device Identification (UDI) mandates to EU MDR compliance and ISO 13485 standards, every label must meet strict regulations for traceability, serialization, and patient safety.
Traditional pre-printed labels often create bottlenecks—delaying production, generating costly waste, and increasing the risk of non-compliance. Afinia Label’s on-demand printing solutions give you the flexibility to print only what you need, when you need it, ensuring accuracy and agility across your entire labeling process.
Why Medical Device Labeling Is Challenging
- Frequent Regulatory Changes
- Global markets require updates to comply with FDA UDI, EU MDR, and other regional
standards.
- Global markets require updates to comply with FDA UDI, EU MDR, and other regional
- Version Control & Traceability
- Labels must include lot numbers, expiration dates, and device identifiers with complete
accuracy.
- Labels must include lot numbers, expiration dates, and device identifiers with complete
- Multi-Language & Localization Requirements
- Expanding into new markets means updating labels for multiple languages and layouts.
- High Audit Scrutiny
- Compliance inspections demand full transparency, print quality, and digital traceability.
- Inventory Waste
- Pre-printed label stock often becomes obsolete after product revisions or regulatory
updates.
- Pre-printed label stock often becomes obsolete after product revisions or regulatory
How Afinia Label Helps
Our industrial color label printers empower medical device manufacturers to:
- Print serialized, UDI-compliant labels on demand
- Reduce label waste and eliminate obsolete stock
- Ensure consistent print quality for critical information
- Easily integrate with ERP, MES, or QMS systems
- Streamline label approval workflows for faster time‑to‑market
By bringing label printing in‑house, you maintain complete control over design changes,
serialization, and regulatory updates—without waiting on external suppliers.
Applications in the Medical Device Industry
- Implantable Device Labels
- Ensure accurate UDI and batch tracking for critical implants.
- Surgical Instrument & Packaging Labels
- High-resolution printing for sterile barrier packaging.
- Clinical Trial & Small-Batch Labels
- Print exactly the quantity you need for testing and limited runs.
- Instructions for Use (IFU) & Regulatory Inserts
- Easily update multi-language IFUs with no minimum order quantities.
- Multi-Language & Global Market Packaging
- Adapt labels quickly for international distribution.
Benefits for Regulatory Compliance
With Afinia Label solutions, you can:
- Stay audit‑ready with complete label traceability and version control.
- Quickly adapt to regulatory changes without production delays.
- Reduce risk of mislabeling or misbranding under the Federal Food, Drug, and Cosmetic Act (FFDCA).
- Scale production while maintaining compliance and quality standards.
Future‑Proof Your Medical Device Labeling
Afinia Label printers help you stay compliant, agile, and cost-efficient—while maintaining the highest level of patient safety and product traceability.
Explore our printers for medical device labeling and discover how on‑demand printing can transform your operations.
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