Materion Precision Coatings, a Materion Corporation business segment, announced that its Large Area Coatings facility in Windsor, Conn. has successfully completed the ISO 13485:2003 Quality Management System registration audit and is now certified at this high-level ISO standard. ISO 13485 is an exacting standard for the design, development, manufacturing and servicing of medical device products requiring an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements with an emphasis on patient safety. It requires the application of risk management to all stages of product realization and builds on the ISO 9001 Quality Management System, which Materion has held since 2009.
 
Materion Precision Coatings is a provider of medical coatings and enabling thin film electrode solutions for devices that allow diabetics to monitor their blood sugar, help patients manage their pain, and enable biological and chemical testing at the point of care. Manufacturers of these devices rely on Materion to produce high quality, thin film coatings that meet unique requirements and precise tolerances, including all required documentation and risk assessment measures.
 
“We partner with the world’s producers of medical diagnostic test strips and flexible biosensors to develop and launch more accurate and lower-cost products,” said Dr. Ian Tribick, president of Materion Large Area Coatings. He added, “Attainment of this certification further demonstrates our commitment to the medical device industry and our continuing support of our customers’ demanding quality requirements.”
 
Materion Corporation is headquartered in Mayfield Heights, Ohio. The company, through its wholly owned subsidiaries, supplies highly engineered advanced enabling materials to global markets. Products include precious and non-precious specialty metals, inorganic chemicals and powders, specialty coatings, specialty engineered beryllium alloys, beryllium and beryllium composites, and engineered clad and plated metal systems.