Medical Device Labels
For more than 30 years, ATL has followed exact specifications from our customer’s disposable device drawings and all required regulatory requirements. As a long time label printer, it was a natural fit for us to provide medical device label services following these same standards.
When required, medical device labels manufactured at our facility have a systematic review before production. This includes APQP (Advanced Product Quality Planning),as well as ISO-14971 risk analysis for specifications, materials, tooling, control plans, performance qualifications, and batch inspection records.
Some medical device labelling capabilities include:
- Medical Device Product and identification labels
- Multiple Panel and Extended Content IFU labels
- Small Diameter Vial and Tube labels
- Assistance with Sterilization and Packaging Services
- Security and Tamper Evident labels
Our Quality Management System (QMS) is ISO-13485:2003 registered. ATL’s QMS has "Travelers" and "Hold Points" that assure line clearance, product integrity, and FDA cGMP compliance. Our QMS has successfully passed audits by some of the largest and most demanding medical and pharmaceutical companies in the world.
ATL welcomes visitors to tour our facility and discuss their potential label needs. Contact us today to schedule a visit or to learn more about how our medical device labels can meet your requirements.