Exceeding GMP Of Medical Devices At Each Step In The Production Continuum

Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide. Services range from master roll distribution of medical foams and tapes to custom die-cut components with tight tolerances. The company’s success is largely predicated upon adherence to the strict FDA regulations of cGMP compliance to 21 CFR 820 for the manufacture, packaging, and storage of all medical devices.

As a registered medical device manufacturer, quality is paramount. To ensure quality, ATL is also cGMP compliant to: 21 CFR 210 and 211. As such, a thorough understanding of the importance of strictly adhering to FDA regulations for the safety of consumers and end users is inherent. To ensure quality and safety, our Quality Management System (QMS) and continuous “Systems Validation Protocol” monitor all major product lines and our engineers use the principles of Quality Function Deployment (QFD) and other preventive quality assurance techniques to ensure the highest possible conformance to quality.