Vioptix Gains ISO Certification for its ODISsey™ Tissue Oximeter, opening Global Markets for Product Platform By ViOptix Inc.
[3/13/2006] ViOptix, Inc., a Fremont, Calif., developer and manufacturer of non-invasive local tissue oxygen measuring devices, has received ISO 13485:2003 certification for the design, manufacture and distribution of its ODISsey™ tissue oximeter and sensors. This certification follows a comprehensive audit by a third party auditing firm.
“Certification to the ISO 13485 standard demonstrates the commitment by ViOptix and its management to the highest levels of quality,” said Mark Lonsinger, vice president of operations at ViOptix, Inc. “This certification is a significant milestone for our company as it creates new opportunities to export our products on a worldwide basis. This will further build momentum for the adoption of this industry-leading technology platform.”
The ODISsey™ tissue oximeter has been used in the United States since its FDA registration in January of 2005. Patient trials have also been underway by prominent surgeons at leading healthcare centers in the US and Canada.
ISO 13485:2003 is the global critical standard for medical device manufacturers. It provides a harmonized world-wide quality management standard for the medical device industry, while being compatible with the FDA Quality System Regulations. The International Organization for Standardization created the ISO system as a benchmarking tool for a broad range of global product manufacturers. It encompasses the national standards institutes of 156 countries. ISO certification ensures that product development, supply and trade are efficient, safe and clean. It also facilitates fair trade between countries.
ViOptix developed patent-protected Optical Diffusion Imaging and Spectroscopy (ODIS) technology to monitor tissue oxygen levels in patients during and immediately following surgery. The company’s lead product, the ODISsey™ Tissue Oximeter, has a broad range of potential applications in surgical procedures, including breast reconstruction following mastectomies and digit reattachment. This non-invasive device provides real-time data, thereby helping surgeons make decisions during and immediately after surgical procedures.
Contact:
Roger Ryerson
(415) 362-9930
rryerson@gibbs-soell.com
8/25/2010
