MedMira Receives Highest International Quality Standard for Medical Devices
March 29 2005 - 9:16AM
PR Newswire (US)
MedMira Receives Highest International Quality Standard for Medical
Devices Achieves ISO 13485:2003 Certification as Part of Corporate
Global Marketing Strategy HALIFAX, March 29 /PRNewswire-FirstCall/
-- MedMira Inc., ("MedMira") (TSX Venture: MIR, NASDAQ:MMIRF) the
global market leader in rapid flow-through diagnostic technology,
announced today that it has successfully upgraded its quality
management system to the ISO 13485:2003 standard; the highest
standard of quality in medical device manufacturing. This new
standard is formally recognized by the European Commission as a key
quality assurance requirement for CE Mark approval of medical
devices, such as the rapid HIV test, for the European Union (EU).
"Our rapid testing products are known leaders in global healthcare
markets for three main attributes; our highest quality standards,
excellent performance, and as one of the only true rapid tests
available - with results in just 3 minutes," said Hermes Chan,
President and Chief Operating Officer of MedMira. "ISO
certification is the most recognized quality standard worldwide,
and our newest certification will help to expand our distribution
networks into additional key markets, particularly in the European
Union (EU). We are confident that this advancement will certainly
facilitate the approval of our MiraCare(TM) Rapid HIV Test by the
EU Notified Body." The International Organization for
Standardization (ISO) is a network of the national standards
institutes for 148 countries, with its coordinating central
secretariat in Geneva, Switzerland. The ISO 13485:2003 standard is
specific to medical device manufacturers, with the primary
objective of facilitating harmonized medical device regulatory
requirements for quality management systems. This standard is
intended to serve as a means for multi-national trade, therefore
significantly improving the possibilities for a medical device
manufacturer to successfully compete for a share in the global
market. ISO 13485 specifies the requirements for an organization's
quality management system by concentrating on the processes most
essential to the final product's quality and safety and through
demonstration of its ability to provide medical devices that
consistently meet customer and regulatory requirements. About
MedMira MedMira is the leading global manufacturer and marketer of
in vitro flow- though rapid diagnostic tests for the clinical
laboratory market. MedMira's tests provide reliable, rapid
diagnosis in just 3 minutes for the detection of human antibodies
in human serum, plasma or whole blood for diseases such as HIV. The
United States FDA and the SFDA in the People's Republic of China
have approved MedMira's Reveal(TM) G2 and MiraWell(TM) Rapid HIV
Tests, respectively. For more information visit MedMira's website
at http://www.medmira.com/. MedMira's Reveal(TM) G2 and
MiraWell(TM) rapid HIV tests are currently used in clinical
laboratories and hospitals where professional counseling and
patient treatment are immediately available. The MiraCare(TM) Rapid
HIV Antibody Test is available over-the-counter (OTC) in pharmacies
throughout the Hong Kong and Macao Special Administrative Regions,
in P.R. China. MedMira markets its rapid tests worldwide in such
countries as the United States, Canada, South Africa and China. Its
corporate offices and manufacturing facilities are located in
Halifax, Nova Scotia, Canada with a representative office in
Beijing, China. This news release contains forward-looking
statements, which involve risk and uncertainties and reflect the
company's current expectation regarding future events. Actual
events could materially differ from those projected herein and
depend on a number of factors including, but not limited to,
changing market conditions, successful and timely completion of
clinical studies, uncertainties related to the regulatory approval
process, establishment of corporate alliances and other risks
detailed from time to time in the company quarterly filings. The
TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this statement.
DATASOURCE: MedMira Inc. CONTACT: Investor Relations: Dr. James
Smith, (902) 450-1588 or e-mail:
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