Longmont, Colo.-based Acertara Acoustic Laboratories—an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory; and ISO 13485:2016 certified probe repair and new product development facility—announces that it has received the latest version of accreditation from the American National Standards Institute National Accreditation Board for ISO/IEC 17025:2017 for ultrasound acoustic testing and calibration.
Acertara CEO G. Wayne Moore spoke out about this achievement, commenting: “The transition from the previous standard, ISO 17025:2005, to the new standard, 17025:2017, was very challenging as the depth of additional requirements with the new standard was extensive. In fact, Acertara is now one of only three acoustic laboratories in the world with this scope of accreditation and the only one in the United States.”
Moore adds: “Our lab provides acoustic testing services for original equipment manufacturers on a worldwide basis in support of their FDA 510(k) ultrasound submissions, and for EU requirements to obtain CE labeling. Our work in this area also supports our probe repair service through verification and validation of materials and components used in the repair process.”
Among other elements for accreditation, ISO 17025:2017 requires objective evidence that the laboratory demonstrates technical competence for a defined scope and the operation of a laboratory quality management system. Part of evidence-based proficiency testing comes through inter-laboratory comparisons using specified technical parameters to ensure testing accuracy among peer-laboratories, Acertara officials reveal.