Biofisica Completes ISO 13485 Certification and CE Mark Submission


Atlanta, GA – 4 April 2006 - Biofisica, one of the most technologically advanced tissue engineering companies in the world, has successfully been ISO 13485:2003 certified and submitted their technical file for CE Marking. Successful certification was made possible by utilizing the Vintara software portal for quality management. The company was formed in 2000 for the purpose of developing, manufacturing, and selling unique and cost effective solutions for the soft tissue regeneration market. State-of-the-art wound care devices currently under development are based on novel and proprietary technology platform that uses the well-known principle of Bio-Electric Stimulation Therapy for soft tissue wound healing. Biofisica has created a unique therapeutic modality that harnesses the natural current of healing. The technology at the core of these products has been proven experimentally in laboratory and clinical settings over the past 20 years. Biofisica’s first commercial offering POSiFECT TM RD is due to be launched in Europe later this year.

Tracy Weldon, VP Operations and Regulatory Affairs, stated: “Biofisica has completed the development of its Quality System. This is a key requirement enabling Biofisica to obtain ISO 13485:2003 certification and FDA’s Quality System Regulation compliance. Ultimately our goals include the CE product mark. As of March 2006, Biofisica has submitted the technical file for CE marking. Our Quality System is comprised of well over 50 detailed operating procedures, directives, rules, and a comprehensive Quality Manual which will govern every aspect of our day to day operations. It dictates how Biofisica works and communicates with its suppliers, customers, and government agencies around the world. Our Quality system is made possible by partnering with Vintara and utilizing their software portal for quality, process, and content management. The virtual system allows Biofisica users access to documents and records from anywhere in the world and is one of the main factors contributing to the company’s successful structure.”

About Vintara: Vintara is the leading provider of web-based, enterprise process management solutions and services for the medical device industry. 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. 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 delivers the solutions that help the enterprise manage their key business processes setting the path to continual improvement.



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