QTS offers a full range of medical device labeling services designed to meet your unique specifications and industry regulations. From the design of your label to ensuring labels meet domestic and international label compliance requirements, QTS works diligently to deliver precise label printing for all your medical devices.
Medical Device Label Development and Printing
QTS offers a validated labeling system to ensure compliance with the Code of Federal Regulations (CFR) and ISO label content guidelines. Our labeling system at QTS brings our clients an enterprise level solution for all your product labeling needs. We can help customers implement GS1 and HIBC package barcodes, and can assist clients with understanding and implementation of Unique Device Identification (UDI) compliant labeling. We’re experts in medical device label development and printing so you don’t have to be.
Our Medical Device Labeling and Printing Services
Our label development process begins and ends with the client’s project goals in mind. We incorporate many important data elements into your medical device labels, including:
- Complete, accurate and validated customer-supplied product information
- UDI compliant barcodes
- Catalog numbers
- Material specifications
- Lot numbers and other identifying information
- Expiration dates
- EN980 symbols
- Language translation
Our label printing services take into account the many and varied environments medical device labels may be subjected to during packaging, shipping, storage and eventual use. Moisture-resistant labels, labels able to withstand extreme temperatures and more are available.
QTS can help your company implement serialization for your medical device products. Whether you have serialized individual devices, devices requiring complex sub-assembled serialized parts, or kits with several serialized devices within them, our ERP system can provide you with all the traceability measures required in the medical device industry. QTS can accommodate devices with predetermined serial numbers or aid you in developing a robust process which we will use to generate serial numbers on your behalf. Our Engineering team can also help incorporate product serialization into your ISO and UDI compliant package labeling and barcodes using our validated label software.
QTS utilizes the following label standards and equipment:
- ISO 15223 – Symbols to be used with medical device labels
- 21CFR801 & 21CFR830, Labeling and UDI
- GS1 & HIBCC – UDI compliant barcoding
- Validated barcode verification system (print quality and decoding)
- Thermal transfer printers (300 DPI & 600 DPI)
For expert medical device labeling and printing services, speak with a QTS representative today. Contact us.