Elevating Medical Device Quality Through Rigorous Certifications: The ATL Corp Advantage
At ATL Corp, quality is the foundation of everything we do. Our commitment to excellence is reflected in our robust Quality Management System and the prestigious certifications we've earned. These certifications aren't just accolades; they're tools we leverage to ensure we deliver the highest quality medical devices to our customers.
ISO 13485:2016 Certification
The ISO 13485:2016 certification is a testament to our adherence to stringent quality management standards specific to the medical device industry. This certification, set by the International Organization for Standardization (ISO) mandates rigorous regulatory requirements that ATL consistently meets and exceeds.
As an ISO 13485:2016 certified manufacturer, our Quality Management Team meticulously documents every process and procedure. The rigorous documentation ensures traceability and accountability at every stage of production. Regular audits, both internal and by ISO registrants, reinforced our commitment to maintaining these high standards. Through continuous compliance and periodic recertification, we adapt to evolving regulations, ensuring our products meet the latest global standards.
FDA Registration and cGMP Compliance: A Dual
Assurance of Quality
ATL Corp is an FDA-registered medical device manufacturer, complying with the Current Good Manufacturing Practice (cGMP) regulations outlined in 21 CFR 210, 211, and 820. This dual assurance of quality through both ISO 13485:2016 and FDA cGMP compliance demonstrates our dedication to producing safe, effective, and reliable medical devices.
State-of-the-Art Cleanroom Manufacturing
Our ISO Class 7 and ISO Class 8 certified cleanrooms are pivotal to our manufacturing process. These controlled environments filter out pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors to extremely low levels. This ensures that every medical device we produce meets the highest standards of cleanliness.
In our cleanroom facilities, the traceability of raw materials, production lots, staff, and equipment are carefully maintained. This traceability is critical for quality control and regulatory compliance, providing our customers an additional layer of assurance.
Leveraging Certifications for Continuous Improvement
At ATL Corp, certifications are not just about meeting regulatory requirements; they are integral to our philosophy of continuous improvement (CI). Our CI initiatives are driven by customer feedback, insights from competitive analysis, and the dedication of our employees. This relentless pursuit of improvement ensures that we are always at the forefront of innovation and quality in the medical device industry.