Award is Key Milestone in Company's Plan to Achieve CE Marking in 2003
WEST BRIDGEWATER, Mass., Jan. 15 /PRNewswire-FirstCall/ -- Boston Biomedica, Inc. (Nasdaq: BBII) today announced that its BBI Diagnostics facility in West Bridgewater, MA has been awarded ISO13485 (2001) certification by G-MED. ISO13485 is an international standard for quality systems more rigorous than ISO9001 and designed specifically for medical device manufacturers. Achievement of ISO13485 certification is the culmination of more than a year of effort by the entire BBI Diagnostics' staff. BBI achieved ISO9001 certification in 1997.
Beginning in late 2003, European Union (EU) regulations require that medical device manufacturers who wish to sell their products in EU countries must apply for and obtain a 'CE Mark' for each product. ISO13485 certification is an essential step toward demonstrating BBI's compliance with the EU regulations. With this certification in place, BBI Diagnostics is nearer to the goal of achieving CE marking for many of its quality control products, particularly those in its Accurun(TM) product line.
"The management group at BBI Diagnostics is especially proud of the entire staff for their focused effort to qualify for ISO13485 certification, which was an important part of BBI's Commitment to Excellence program for 2002," commented Janet O'Connor, Director of Manufacturing and Quality Assurance for BBI Diagnostics. "Our CE marking effort will continue throughout this year, and with the continued support of our employees we are confident that this goal, too, will be met."
"We believe that CE marking will enhance and expand our relationship with our customers, continue to reinforce to the international market our commitment to providing the highest quality products, and help us achieve our ultimate goal of increasing revenue from international sales. Toward this end, CE marking of Accurun products before the end of 2003 will allow us to avoid regulatory issues that may adversely impact the sale of diagnostic products in EU countries going forward, and thus it has been a high priority for some time," said John Swatosh, Director of Marketing and Sales for BBI. "In addition, and very importantly, ISO13485 certification demonstrates our commitment to our partners in the worldwide distribution of BBI products, as well as our continuing commitment to excellence in product quality and customer support."
Boston Biomedica, Inc. provides products and services to the diagnostics and life sciences industries to evaluate, monitor, and ensure the quality of infectious disease test results, to improve the preparation of specimens for genomic/proteomic testing, and to safely store and retrieve rare and valuable biological specimens. We also manufacture biological reagents used in test kits and provide a broad range of routine and esoteric research services to governments and industry. BBI operates in three states, and conducts research in new applications for our patented Pressure Cycling Technology (PCT). In 2000, we launched Panacos Pharmaceuticals, and the Company maintains a significant passive investment in this novel antiviral drug development company.
Statements contained in this news release that state the Company's or management's intentions, hopes, beliefs, expectations or predictions of the future are "forward-looking" statements. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Factors that could cause actual results to differ from those projected include the possibility that the Company may not achieve CE marking for some or all of its QC products, or that such CE marking may take longer than expected. In addition, CE marking may not help increase sales in international markets. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filings, including but not limited to the Company's Annual Report on Form 10-K for the year ended December 31, 2001, and the Company's quarterly reports on Form 10-Q for the three months ended March 31, June 30, and September 30, 2002. Copies of these documents may be obtained by contacting the Company or the SEC.
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SOURCE Boston Biomedica, Inc.