Acertara Upgrades to ISO 13485:2016 Certification
LONGMONT, CO October 8, 2018. 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,” said 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.”
Acertara Acoustic Laboratories, located in Longmont, Colorado is an independent ISO/IEC 17025:2005 accredited advanced acoustic measurement, testing, and calibration facility providing diagnostic and therapeutic acoustic power testing and measurement services to ultrasound OEMs, researchers, and regulatory bodies around the world. Acertara also manufactures and sells a complete line of acoustic power testing products; including its industry standard Acoustic Power Lab Suite and AMS software. Acertara also manufactures and sells probe testing devices; Aureon™, AmpSafe™ and ATLAS™. Acertara offers contract-based advanced ultrasound research and product development and engineering design services. Acertara is also ISO13485:2016 certified for ultrasound probe repair. Additional information for Acertara is available on its website at www.acertaralabs.com, or contact firstname.lastname@example.org. Acertara Acoustic Laboratories, LLC is a Veteran owned and operated business.
Acertara Acoustic Laboratories
1900 S. Sunset St., Unit F
Longmont, CO 80501