Atlanta, GA, December 19, 2012 – Matrix Surgical USA announced today that it has received CE Mark approval as well as certification for ISO 13485:2003 for its OMNIPORE® High-density Porous Polyethylene craniofacial implants for reconstructive and aesthetic craniofacial surgery. Manufactured in the USA, OmniPore Surgical Implants meet the highest standards for quality and reliability, providing surgeons with an expanded range of options to achieve the best possible outcome for their patients.
“We can now provide surgeons in all countries recognizing the CE Mark with OmniPore Surgical Implants. These state-of-the-art sterile devices are of the highest quality and provide a cost-effective solution to the difficult challenges faced by craniofacial surgeons every day,” said John O’Shaughnessy, President and CEO of Matrix Surgical USA. “We believe that our years of industry experience have contributed to reaching these important goals ahead of schedule.”
“Achieving ISO certification, combined with our CE Mark, opens the door for worldwide distribution of our products,” said Alvaro Rodriguez, Executive Vice President of Sales. “It demonstrates our commitment to meeting customers’ requirements for the highest quality products.”
Matrix Surgical USA has filed a 510(k) submission with the FDA for permission to market OmniPore Surgical Implants in the US marketplace.
The ISO 13485:2003 certification confirms that Matrix Surgical USA meets the requirements for a comprehensive Quality Management System for the design, development and manufacture of medical devices from its U.S. headquarters facility. ISO 13485 is an internationally recognized quality standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet the specific customer and regulatory requirements applicable to medical equipment.