www.fdanews.com/articles/70490-medmira-receives-highest-international-quality-standard-for-medical-devices
MedMira Receives Highest International Quality Standard for Medical Devices
March 30, 2005
MedMira, developer of rapid flow-through diagnostic technology, announced 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.
Canada NewsWire (http://www.newswire.ca/en/releases/archive/March2005/29/c9214.html)