You are here
Immunexpress Achieves ISO 13485:2016 & EN ISO 13485:2016 Quality Certification for Worldwide Commercialization of SeptiCyte® RAPID
BRISBANE, Australia and SEATTLE, Feb. 27, 2020 /PRNewswire/ -- Immunexpress, Pty Ltd & Inc., a molecular diagnostic company with the first FDA cleared host response assay for suspected sepsis patients, today announced that it has been successfully certified according to ISO 13485:2016 & EN ISO 13485:2016, the international standard for medical device quality management systems. The scope of the certification includes the design and control of manufacture of molecular in vitro diagnostic (IVD) tests to aid in the detection and identification of infectious pathogens and the associated host immune response in human subjects. ISO 13485:2016 & EN ISO 13485:2016 certification is a key step towards marketing the Company's products in European, North American and many Asia/Pacific countries, including Australia where Immunexpress was founded.
"Achieving the International Organization for Standardization certification for our quality management system reflects our commitment to the development of innovative, safe and effective products for the global market," said Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress. "Our team's quality-focused culture led to the completion of this milestone, an achievement that we believe will translate directly into measurably improved outcomes for patients. Our dedication to quality and regulatory compliance ensures SeptiCyte® is the most robust diagnostic tool for sepsis."
The review was performed by BSI, the business improvement company and one of the world's leading Notified Bodies offering the latest quality management systems certification specific to the medical device industry.
"Immunexpress' certification to ISO 13485 demonstrates their commitment to quality and safety," said Bill Enos, Senior Commercial Operations Director, Regulatory Services for BSI in the U.S. "Maintaining a consistent level of quality, at all levels of the organization, and throughout the manufacturing process, is essential to the end product and the impact to patient safety."
As part of the ISO certification process, Immunexpress participated in a thorough, independent, two-stage audit of its quality management system as well as its product quality requirements. In September 2018, the U.S. Food and Drug Administration announced plans to transition medical device manufacturers to a system based on the ISO 13485 standard.
BSI is the business improvement company that enables organizations to turn standards of best practice into habits of excellence. For over a century BSI has championed what good looks like and driven best practice in organizations around the world. Working with 84,000 clients across 193 countries, it is a truly international business with skills and experience across a number of sectors including aerospace, automotive, built environment, food, and healthcare. Through its expertise in Standards Development and Knowledge Solutions, Assurance, Regulatory Services and Consulting Services, BSI improves business performance to help clients grow sustainably, manage risk and ultimately be more resilient and trusted. Learn more at bsigroup.com.
Immunexpress is a Seattle-based molecular diagnostic company committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte® technology can assess a patient's immune response by quantifying and analyzing gene expression signatures from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID combines SeptiCyte® technology with the Biocartis' Idylla™ platform*, empowering clinicians to swiftly differentiate systemic inflammatory response syndrome (SIRS) from sepsis in critically ill patients to be admitted to the ICU. This powerful combination of technologies enhances certainty for early sepsis diagnosis, to improve clinical outcomes and lowers healthcare costs.
*Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.
Russo Partners, LLC
View original content to download multimedia:http://www.prnewswire.com/news-releases/immunexpress-achieves-iso-134852016--en-iso-134852016-quality-certification-for-worldwide-commercialization-of-septicyte-rapid-301012520.html
SOURCE Immunexpress, Inc.