SAN JOSE, Calif., July 14, 2023 -- Cephasonics, a leader in AI-enabled OEM ultrasound platforms and development systems, today announced that it has received ISO 13485:2016 certification.
Cephasonics recently completed its ISO 13485 audit and has received certification from American Systems Registrar that its quality management system for engineering and design as well as manufacturing have met the ISO13485 requirements.
(American Systems Registrar (ASR) is an ANAB accredited and IATF approved registrar.)
Randall Whiting, Chief Operating Officer of Cephasonics, stated, “The receipt of the ISO certification helps validate our strong commitment to quality through out device, manufacturing and customer support areas. Notably, this ISO certification marks the continuation and acceleration of our commitment to providing best-in-class OEM platforms for developing next generation medical ultrasound systems that support our customers' requirements.”
ISO 13485:2016 an internationally recognized quality standard that is intended to ensure that medical devices and related services have consistent design, development, production, and sale of products that are fit for purpose as per intended use. To be certified, organizations must demonstrate that their Quality Management Systems are able to provide products and related services that consistently meet customer and applicable regulatory requirements.
Cephasonics is a worldwide OEM supplier of precision real-time ultrasound systems that help companies and researchers design, develop and produce next generation clinical ultrasound imaging products and solutions. Cephasonics is ; advancing ultrasound with AI-enabled real-time data-driven capabilities that enable ultrasound to be used in a myriad of new ways from assisting medical robotics, to providing real-time data to doctors and surgeons, all without the need for trained specialists.