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FDA Compliance

MedMira Announces ISO 13485:2003 Registration

Published: Tuesday, April 26, 2005 - 22:00

MedMira Inc. has recently achieved registration to ISO 13485:2003.MedMira, a provider of rapid flow-through diagnostic technology, reports that the standard is formally recognized by the European Commission as a key quality assurance requirement for the CE Mark approval for medical devices. ISO 13485:2003 is specific to medical device manufacturers, with the primary objective of harmonizing medical device regulatory requirements for quality management systems.

“ISO certification is the most recognized quality standard worldwide and our newest certification will help expand our distribution networks into additional key markets, particularly the European Union,” says Hermes Chan, president and CEO of MedMira. “We’re confident that this advancement will certainly facilitate the approval of our MedMira Rapid HIV Test by the EU Notified Body.”

For more information, visit www.medmira.com.


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