Medmira (PK) (USOTC:MMIRF)
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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: