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Quality Management System & Certifications

ISO 13485:2016 A strong quality system leads to consistently high-quality products. At ATL, quality is paramount to both our customers and us. Our Quality Management System is registered to ISO 13485:2016. ATL is an FDA registered medical device manufacturer and cGMP compliant to 21 CFR 210, 211, and 820. We have ISO Class 7 and ISO Class 8 manufacturing clean rooms.

ISO 13485 Certification 

ISO 13485 is an official Quality Management System Certification set by the International Organization for Standardization for the manufacture of medical devices. This certification enforces regulatory requirements that must be met by the organization. ISO 13485 registered manufacturers are periodically audited to ensure continued compliance and recertification as the regulations evolve.  

As an ISO 13485 certified manufacturer, our Quality Management Team ensures all requirements are met. This is done by documenting all processes and procedures. Rest assured, ATL is committed to maintaining a robust Quality Management System that results in producing consistent, high-quality products. 

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Cleanroom Manufacturing 

ISO Class 7 and ISO Class 8 compliant cleanrooms are controlled environments that filter pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors to very low levels.

As an ISO 13485 contract manufacturer, the raw material, production lot, staff, and equipment traceability used to produce every order is an integral part of our operations. 

We maintain a strict internal audit function in conjunction with ISO registrant re-certifications, regulatory agency reviews, and customer audits.

Continuous Improvement (CI) is critical to our ongoing success. We are driven by our customers, competition, and, most importantly, our employees, who recognize the value of getting better every day and moving our business forward.

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