US-based MBio Diagnostics has received ISO 13485: 2003 certification for its quality management system.
As per the ISO requirements of the quality management system, an organization should show its ability to serve medical devices and related services that consistently meet the customer requirements.
MBio Diagnostic CEO Christopher Myatt said achieving this certification is a significant milestone that brings the company closer to the launch of its first product.
"We believe this achievement reinforces our commitment to quality and to our customers," Myatt added.
MBio Diagnostics Regulatory Affairs and Quality Assurance vice president Sue Sutton-Jones said, "All of us on the MBio team are confident that this will provide a solid foundation for our development, clinical, regulatory, manufacturing and commercial activities going forward."