"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.