June 24, 2014
June 24, 2014 - ABT Molecular Imaging, Inc. manufacturer of Biomarker Generator Systems, announced today that it has achieved EN ISO 13485: 2012 certification for its quality management system for the design, manufacture and service of Biomarker Generator Systems and related accessories. BSI, one of the world’s leading certification bodies, awarded the certification.
EN ISO 13485:2012 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.
Peter Kingma, CEO & President of ABT Molecular Imaging, stated today that “ABT Molecular Imaging, Inc is proud to be granted this mark of recognition for our quality systems and processes. ISO 13485 opens doors for regulatory recognition in several key markets, as well as ensuring the quality and consistency of the products that we deliver to our customers”.
Matthew Solis, Director of Quality Assurance for ABT Molecular Imaging, Inc., offered that “All of us in ABT Molecular Imaging, Inc. are confident that this will provide a solid foundation for our design, development, manufacture, test, distribution and service of our Biomarker Generator Systems and Dose Synthesis Cards going forward. Achieving this certification is a significant milestone for ABT Molecular Imaging, Inc. and we believe this achievement reinforces our commitment to quality and to our customers.”
About EN ISO 13485: 2012
EN ISO 13485: 2012 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.
About ABT Molecular Imaging, Inc.
ABT Molecular Imaging, Inc designs, manufactures and distributes an affordable, small-footprint Biomarker Generator™ for PET imaging agents. The Biomarker Generator produces individual doses of sterile, quality-controlled contrast material on-demand, in a prepared syringe, for injection directly into a patient. ABT’s Biomarker Generator is opening global markets to PET by offering a fully-automated, affordable solution at the point-of-care. ABT was founded in 2006 by Dr. Ron Nutt, founder of CTI Molecular Imaging, which Siemens acquired for $1.1 billion in 2005.