Demonstrating Internationally Recognized Standards for Quality Management in Development and Manufacturing Medical Devices
Knoxville, TN (August 22, 2016) – EDP Biotech, a privately-held company providing in-vitro diagnostic test kits for the detection of colorectal cancer, has successfully re-certified its Quality Management System (QMS) under ISO 13485 and Canadian Medical Device Regulations. The re-certification includes the design, development and production of its first product, the ColoMarker® ELISA kit.
“EDP Biotech’s re-certification of the ISO 13485 and CMDCAS QMS demonstrates our company’s commitment to quality and attention to detail in the development and provision of ColoMarker brand products, laying a solid foundation for the future growth of EDP’s clinical diagnostics business,” stated Dennis Forbush, Director of Quality Assurance and Regulatory Affairs at EDP Biotech.
“With our re-certification, EDP continues on its path to deliver world-class diagnostic products aimed at filling the unmet needs of patients and clinicians, starting with the launch of ColoMarker – an accurate and cost-effective method of detecting early stage colorectal cancer,” stated Eric Mayer, CEO at EDP Biotech.