Demonstrating Internationally Recognized Standards for Quality Management in Development and Manufacturing Medical Devices and Related Services
Knoxville, Tn. (Oct 28, 2015) – EDP Biotech, a privately-held company providing in-vitro diagnostic test kits for the detection of colorectal cancer, has achieved ISO 13485 and Canadian Medical Device Regulations Certification. The certification includes the design, development and production of its first product, the ColoMarker® ELISA kit, an enzyme immunoassay in vitro diagnostic test kit to aid in the detection of colorectal cancer in patients 50-75 years of age.