PrimeraDx Receives ISO 13485:2003 Certification | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – PrimeraDx said on Wednesday that is has received ISO 13485:2003 certification.

The certification is used to create a standardized quality system for designing and manufacturing medical devices. BSI Group America performed the certification according to ISO 13485:2003 requirements and focused on the Mansfield, Mass.-based molecular diagnostic firm's design, manufacturing, and distribution operations.

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