YUCAIPA, Calif., March 8, 2010 (GLOBE NEWSWIRE) -- Ingen Technologies, Inc. (Pink Sheets:IGNT), a leading manufacturer of respiratory medical devices, recently announced today that the company was granted approval of the Stage-II audit conducted by BSI America, Inc. on March 2, 2010, and the Auditor has recommended Ingen for ISO 13485 certification.
Accordingly, the auditor had recommended that the scope of activities detailed in his report meet registration requirements and that the recommendation would be independently verified within BSI. Upon final verification, the ISO 13485 certificate of registration will be issued. Further, the company will meet CE Mark requirements for Europe. Customarily, the company expects to receive its certificate in 4-5 weeks.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services in order to market and sell their product in various countries.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
"We believe that this ISO certification is a major part of our critical path to generating substantial revenues for this company. With initial pending back-orders in Europe, Asia and Australia, we expect to see $11M in sales in 2010. In addition, our General Services Administration (GSA) application is expected to be approved this month, and KGMA Business Solutions has already begun working on a distribution program," stated Scott R. Sand, Chief Executive Officer and Chairman of the Board.
http://www.emergogroup.com/services-by-region/usa
http://www.smartnasalcannula.com/
http://www.ingenpulseoximeter.com/
http://www.oxyviewnasalcannula.com/default.html
About Ingen:
Ingen is an established medical device manufacturer with an emerging new medical product line for the respiratory market worth an estimated $4 Billion in the U.S., and $8 billion globally. The company introduced Oxyview into the respiratory market in late 2007 after securing U.S. and Foreign Patents and a successful registration with the Food & Drug Administration. The company has domestic and global distribution with manufacture representative organizations, and OEM partners. In 2009 the Oxyview Nasal Cannula was introduced as the world's first oxygen cannula with an in-line pneumatic oxygen flow meter. In 2010 the company introduced the Oxyview Pulse Oximeter. The Oxyview product line is available to the home care markets, commercial medical markets, aviation, automotive, and government sources. The company is licensed with the Department of Health and Human Services, and manufactures its products in the State of California. With approximately 32 million U.S. patients with Chronic Obstructive Pulmonary Disease (COPD), and 600 million patients worldwide, Ingen Technologies is now the largest manufacturer of in-line gravity-independent oxygen flow meters.
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Safe Harbor for Forward-Looking Statements: This news release includes forward-looking statements. While these statements are made to convey to the public the company's progress, business opportunities and growth prospects, readers are cautioned that such forward-looking statements represent management's opinion. Whereas management believes such representations to be true and accurate based on information and data available to the company at this time, actual results may differ materially from those described. The company's operations and business prospects are always subject to risk and uncertainties. Important factors that may cause actual results to differ are and will be set forth in the company's periodic filings with the U.S. Securities and Exchange Commission.