Disposable Medical Devices
As an FDA registered medical device manufacturer and a 3M Medical Preferred Converter, ATL manufactures custom disposable medical components for shipment worldwide.
Medical industry leaders trust our services, which range from master roll distribution of medical foam and tapes to custom rotary die cut components with tight tolerances. Our experienced engineering team will work closely with you on material selections and prototypes, critical-to-quality characteristics, and cost efficient production methods.
ATL is ISO 13485:2003 registered and follows the strict FDA regulations of cGMP compliance to 21 CFR 820 for the manufacturing, packaging, and storage of medical devices.
Medical and Pharmaceutical Labels
Every new design for pharmaceutical and medical labels to be manufactured in our facility has a systematic review before production. This includes APQP (Advanced Product Quality Planning) for specifications, materials, tooling, control plans, performance qualifications, and batch inspection records.
Our Quality System has "Travelers" and "Hold Points" that assure line clearance, product integrity, and cGMP compliance. Only our Quality Assurance department is authorized to release the product at each hold point, and only after conformance to specifications is achieved.
Top companies in the medical and pharmaceutical industries trust ATL based on their regular audits of our quality systems, validation protocols, and traceability of product.