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Press Release
Florida Anodize System & Technologies, Inc., Pioneer of Sterilization Resilient Anodic Coatings for Surgical Products, Receives ISO Certification
Sanford, FL-- 07/09/2019 – Sanford-based Florida Anodize System & Technologies, Inc. (“FAST”) announced today that its quality management system for medical device surface coating services has been audited by TÜV SÜD and found to be in full compliance with the International Organization for Standardization (ISO) 13485:2016 standard.
The 2016 revision of the ISO 13485 standard applies to organizations involved in the design, production, installation, and servicing of medical devices and related services and places significant emphasis on risk management, risk-based decision making, and regulatory requirements for global supply chains. With this certification, FAST signals its commitment to being an innovative leader in the medical device surface treatment industry, while exceeding customers' quality, safety, and performance expectations.
FAST has been assessed and certified by premier Notified Body, TÜV SÜD for the application of surface coatings for medical devices, including its best-in-class FAST ColourLock™ anodic coating. Headquartered in Munich, Germany and founded in 1866, TÜV SÜD is a world leader in testing, product certification, inspection, auditing, and system certification for medical devices.
Medical device manufacturers are increasingly relying on human factors design principles, including color differentiation, to reduce operator error and improve patient outcomes related to reusable medical devices. Healthcare systems are also adopting severe sterilization processes using ethylene oxide, vaporized hydrogen peroxide, and high alkaline cleaners to reduce hospital-acquired infection rates. FAST specializes in anodic coatings that withstand repeated exposure to these harsh sterilization methods and retain both color and coating integrity, meeting both manufacturer and provider requirements for patient safety.
According to Vice President Neel Patel, “FAST has over 20 years of experience in the industry, and the FAST ColourLock™ process for medical devices is proven to be a high quality and repeatable at scale. Additionally, with this latest ISO certification, our management team and ownership further commit to upholding the stringent quality standards that make us a reliable partner and the leader in the medical anodic coating field.”
For more information, visit www.anodizefast.com, or call 1-407-302-3278.
About Florida Anodize System & Technologies, Inc.
Florida Anodize System & Technologies (FAST) is an industry leader in tight-tolerance aluminum anodic coatings for the medical and surgical device industry. Serving Top 30 Global MedTech OEMs for over 20 years, FAST takes pride in its quality-based culture, ethos of putting customer needs first, and recently achieved ISO 13485:2016 certification. It's premier offering, FAST ColourLock™, does not sacrifice attractiveness for sterilization resiliency and is capable of high-volume, production level application. With an efficient throughput rate and frequent and open communication, FAST works closely with customers to be a highly synchronized global supply partner.
