CAMBRIDGE, MA—December 21, 2009— IntelligentMDx, a molecular diagnostics company has reached a major milestone achievement in becoming certified to the ISO 13485:2003 Quality Management Systems standards and guidelines. IntelligentMDx has achieved the ISO 13485:2003 accreditation from the Laboratoire national de métrologie et d’essais (LNE/G-MED). ISO 13485 is accepted worldwide as the inclusive international standard that defines quality in the area of medical devices.
IntelligentMDx underwent a stringent evaluation process that included quality management system development, documentation review, pre-audit, initial assessment, and clearance. The process culminated in a comprehensive registration audit by LNE/G-MED. IntelligentMDx received its ISO 13485:2003 certificate of registration on December 17, 2009. The certification of compliance with ISO 13485:2003 recognizes that the policies, practices and procedures of our company ensure consistent quality in the molecular assays that are designed and developed by IntelligentMDx. With this certification, our customers, collaborators and partners can be confident that IntelligentMDx is dedicated to maintaining the highest quality in our products.
About IntelligentMDx:
IntelligentMDx’s mission is to commercialize test solutions under FDA quality system regulations for use in clinical reference labs. To guarantee quality for customers and partners we are compliant with FDA QSR and ISO 13485:2003 guidelines. IntelligentMDx test solutions are designed to be clinically impactful, competitively differentiated, and platform-agnostic test solutions.
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For more information on IntelligentMDx, visit www.intelligentmdx.com or contact Corporate Communications at cc@IntelligentMDx.com, 617-871-6410.