MBio Achieves ISO 13485:2003 Certification | GenomeWeb

NEW YORK (GenomeWeb News) – MBio Diagnostics today said that it has achieved ISO 13485:2003 certification for its quality management system.

The certification means that the Boulder, Colo.-based company has demonstrated that it fulfills certain quality system requirements to provide medical devices and related services that consistently meet customer demands. ISO 13485:2003 certification is often the initial step toward obtaining the CE mark in Europe and in countries that honor the mark.

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