BOULDER, CO--(Marketwired - July 08, 2013) - MBio Diagnostics, Inc. announced today that it has achieved ISO 13485: 2003 certification for its quality management system. BSI, one of the world's leading certification bodies, awarded the certification.
ISO 13485:2003 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements. Typically, it is a first step towards obtaining CE mark, the regulatory clearance requirement recognized in Europe and other countries that indicates that products meet EU safety, health or environmental requirements.
"Achieving this certification is a significant milestone for MBio Diagnostics that brings us closer to the launch of our first product, the MBio CD4 System," said Christopher Myatt, CEO of MBio Diagnostic, Inc. "We believe this achievement reinforces our commitment to quality and to our customers."
Sue Sutton-Jones, Vice President of Regulatory Affairs and Quality Assurance for MBio Diagnostics, Inc., offered that "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."
About ISO 13485: 2003
ISO 13485: 2003 is an international standard, globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices. ISO 13485 is based on quality management principles that have been proven to enhance organization performance. These principals relate to customer focus, management, internal processes and external relationships.
MBio Diagnostics, Inc. (www.mbiodx.com) is a privately held diagnostics and life sciences company based in Boulder, CO. MBio Diagnostics is increasing access to quality healthcare by delivering innovative and low cost point-of-care (POC) diagnostics. The MBio System is initially being commercialized to manage treatment of HIV patients from a single drop of blood. The MBio elegant detection system is being developed for a broad menu of applications including multiplex assays and cellular analysis.