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Oakland, CA – 8 December 2005 - With last month’s signing of Refocus Group, Vintara is rapidly becoming the premier provider for fully automated, web-based quality management software for medical device manufacturers to meet FDA regulatory requirements.
Refocus Group Inc. is a medical device company engaged in the research and development of treatments for human vision disorders. Refocus Group holds over 90 domestic and international issued and pending patents, the vast majority directed to methods, devices, and systems for the treatment of presbyopia and other eye disorders. Presbyopia impacts nearly everyone over age 40. As nearly everyone over 40 knows, our eyes' ability to focus on close-up tasks such as reading diminishes as we age. This condition, known as presbyopia (Greek for "old eye"), eventually affects nearly all of the population past middle age. Historically, the only help for presbyopia has consisted of bifocal or other types of lenses, or reading glasses. Researchers at Refocus Group have developed a revolutionary new technique they believe will prove to be effective in treating presbyopia. In the United States, Refocus Group is currently conducting its Phase III FDA clinical trials.
Dawn Plaskon, Vintara’s Director of Consulting Services stated; “the daunting task of FDA compliance can be distilled in several key steps that by utilizing our software platform will enable organizations like Refocus to quickly and cost-effectively ensure FDA compliance of their quality management systems.” Glenn Kohner, Vintara’s President, added to Dawn’s comments; “with Refocus joining the Vintara family of medical device manufacturers, Vintara is becoming a key enabler of medical device manufacturers to comply both with FDA regulations and ISO 13485 standards.”
About Vintara Vintara is the leading provider of web-based, enterprise process management solutions and services regardless of industry sector. Founded in 1997, Vintara has a proven track record of helping the enterprise successfully prepare for and cost-effectively maintain compliance with a range of domestic and internationally recognized standards. Our customers come from a variety of industries, with a diverse range of needs. Whether a hosted or an in-house server option, in every case, Vintara created solutions that meet and exceed customers’ growing business needs.
Combining innovative technology with training and consulting services, Vintara’s brands – ISO9. ISO13, ISO14, ISO17, OHS18, and Six Sigma – deliver the solutions that help the enterprise manage their key business processes setting the path to continual improvement.
For more information please visit www.vintara.com Or contact us at sales@vintara.com or call toll-free 866.321.4769.
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