PrimeraDx Receives ISO 13485:2003 Certification
Published: Jan 19, 2012
MANSFIELD, Mass., Jan. 18, 2012 /PRNewswire/ -- PrimeraDx today announced that they have received certification for ISO 13485:2003, demonstrating their strong commitment to continuous improvement.
"Achieving ISO 13485:2003 certification is an important milestone and distinguishing differentiator for PrimeraDx. It demonstrates to our customers, collaborators and companion diagnostic partners, that we are dedicated to quality at every level of the organization," said CEO and President Matt McManus.
"Every member of the PrimeraDx team takes an active role in following and supporting our quality policies, allowing us to lead the way in addressing current and future requirements of the clinical diagnostics market," added Fayyaz Memon, Vice President of Regulatory Affairs and Quality Assurance.
This certification is used by medical device service and manufacturing organizations to create a standardized quality system for the design and manufacture of medical devices that meet both customer and regulatory requirements. The review was performed by BSI Group America according to ISO 13485:2003 requirements, and focused on PrimeraDx's design, manufacturing, and distribution of multiplex instrumentation and assays for molecular diagnostics.
PrimeraDx is a molecular diagnostics company that has developed and is commercializing a novel, game-changing clinical platform which combines PCR with capillary electrophoresis. The result of combining these two well-known technologies into a bench-top instrument is the ability to deliver highly multiplexed and quantitative answers to the clinic. The company is pursuing a two-pronged strategy to sell the system in an Open Platform Mode to clinical labs and to collaborate with pharmaceutical companies to develop high-value companion and enabling diagnostic products. Users can easily design very complex multi-modal assays that test for disparate target types, like SNPs, expression biomarkers, microRNAs and fusion genes. PrimeraDx's technology represents the next generation of quantitative PCR. The Company is backed by a strong group of experienced venture-capital investors, including Abingworth, InterWest Partners, CHL Medical Partners, and Malaysia Technology Development Corporation. The Company's website is: www.primeradx.com or www.multiplexpcr.com.
About BSI Group America
Since 1901, BSI has provided customers with impartial third-party standards-based assurance, compliance, information solutions, and training. BSI is a trusted partner to Industry and Government with over 66,000 organizations, in almost 150 countries, working with over 50 BSI global offices. Our mission is to ensure patient safety while supporting timely access to global medical device technology. We provide thorough, responsive, predictable conformity assessments, evaluations, and certifications that are recognized and accepted worldwide. www.bsiamerica.com
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