Koning Health, global leader in advanced breast imaging technology, announced that it has achieved certification under the Medical Device Single Audit Program, or MDSAP, while continuing to expand its U.S. installed base with new Koning Vera Breast CT systems in the greater Seattle area and Richmond, Virginia.
MDSAP is an internationally recognized regulatory audit program that allows a medical device manufacturer's quality management system to be evaluated through a single, comprehensive audit against the requirements of multiple participating regulatory authorities, including those in the United States, Canada, and Australia. The audit examines the systems governing product design, manufacturing, risk management, supplier oversight, complaint handling, and post-market monitoring.
For Koning, this certification provides independent validation that the company's quality and regulatory infrastructure meets rigorous international standards and is a step forward in Koning's global commercialization strategy, particularly following the company's regulatory submissions to Health Canada and Australia's Therapeutic Goods Administration (TGA).
By achieving MDSAP certification, Koning has completed a core quality-system requirement supporting registration in these markets and has materially advanced Vera Breast CT toward commercial availability in Canada and Australia.
"Achieving MDSAP certification is a major milestone for Koning and an important validation of the quality systems supporting our technology," said David Georges, President of Koning. "It strengthens the regulatory foundation for our expansion into several of the world's most important medical device markets while demonstrating our continued commitment to quality, patient safety and operational excellence."
