Longmont, Colo.-based Acertara, a privately-held ultrasound engineering, test product development, and advanced probe repair company, announced that it has achieved ISO 13485:2016 certification for medical device and quality management systems, upgraded from the ISO 13485:2003 certificate. This certification closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.
ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing, and sale of medical devices that are safe and effective for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.
“This certification is further evidence of our unwavering commitment to quality and ensures every Acertara customer—from a hospital probe repair customer to an OEM who purchases complex test equipment—receives products and services that adhere to the highest standards for safety, product performance, and reliability,” says G. Wayne Moore, CEO of Acertara.
“With a focus on maintaining a world-class quality management system and as one of the few privately-owned companies in our market space, Acertara is an organization that customers can confidently rely on in a shifting competitive landscape,” Moore adds.