Label Development & Printing

At Cretex Medical | QTS we provide comprehensive medical device labeling and printing solutions tailored to meet your unique specifications and the strictest regulatory standards. QTS will print and apply the final, controlled, product labeling to your product’s packaging. Our labeling specialists can design custom labeling for your approval, work with your designers to incorporate your labels into our validated labeling system, or connect directly to your own controlled labeling system. We ensure your labels are compliant, durable, and ready for global distribution.

Every label we produce is built around your product’s goals and lifecycle, incorporating:

• UDI-compliant barcodes
• Lot numbers, catalog numbers, serial numbers
• Expiration and manufacturing dates
• Product specifications, EN980 symbols, eIFU links, and logos
• Materials validated to sustain the rigors of sterilization, environmental challenges, and distribution
• Multilingual content and translation support

Our robust systems allow us to customize your labels for unique part information, such as family, size, descriptions, even variations in images and logos.

We utilize industry-leading labeling standards and technologies to ensure accuracy and compliance:

• ISO 15223-1 – Standard medical symbols
• 21 CFR 801 & 830 – FDA labeling & UDI requirements
• GS1 & HIBCC – UDI-compliant barcode formats
• Validated barcode verification – For print quality, grading and decoding
• Thermal transfer printers – 300 & 600 DPI (Black/White)
• Full color inkjet printing – 1,600 DPI

Our labeling capabilities are designed to meet the highest standards for traceability, readability, and global regulatory compliance—ensuring your products are ready for any market.