Label Development & Printing
Full-Service Medical Device Labeling, Designed for Compliance and Precision
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.
Labeling is no after-thought at QTS.
Expertise in Medical Device Label Development
With a fully validated labeling system, QTS helps ensure compliance with FDA regulations, ISO standards, and international labeling requirements. We support:
- UDI-compliant labeling (GS1 & HIBCC)
- CFR 21 Part 801 & 830 requirements
- ISO 15223-1 symbol integration
Our team can assist you in implementing or improving UDI labeling systems, including GS1 and HIBC barcodes, so you’re always audit-ready.
You don’t need to be the labeling experts; we’ve got your back.
Part 830 requirements ensure labels that are easily read and captured automatically, and ensure compliance with international standards.
Labeling Solutions Specific to Your Product Needs
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 have expertise in both U.S. and E.U. regulatory requirements.
Our Label Standards, Systems & Equipment
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.
We can implement labeling solutions specific to your product’s needs, including readability, scannability, and durability.
Let’s Get Started
Whether building compliant labels from the ground up or improving your existing labels, QTS is your partner for quality, reliability, and peace of mind.
Contact us today about your packaging and labeling needs.
