Acertara

medical devices

About

Acertara Acoustic Laboratories is a medical device company based in Longmont, Colorado, specializing in diagnostic ultrasound technology. Founded in 2011 by industry veterans G. Wayne Moore and James Gessert, the company focuses on ultrasound probe repair, acoustic measurement services, and regulatory consulting. Acertara operates an ISO/IEC 17025:2005 accredited laboratory and is ISO13485:2003 certified for probe repair and new product development. The company offers high-quality ultrasound probe repair, quality assurance test products, and engineering services. Acertara is recognized for its pioneering role in the ultrasound quality assurance market and has developed a modern approach to third-party ultrasound probe repair. Their customer base includes hospitals, independent service organizations, and clinics, and they are expanding into ultrasound field service training and exploring other imaging modalities like MRI and CT. Acertara is also known for its regulatory consulting services, assisting medical device manufacturers with FDA compliance.

Technologies

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Keywords

ultrasound fda 510 submission services acoustic power measurement services ultrasound test equipment ultrasound probe repair medical equipment manufacturing ultrasound performance testing ultrasound transducer repair medical ultrasound testing ultrasound safety testing acoustic power measurement regulatory compliance iso 13485:2016 medical equipment and supplies manufacturing acoustic metrology ultrasound device development probe testing ultrasound device regulation b2b fda 510(k) submission probe validation ultrasound testing probe calibration ultrasound probe testing devices fda 510(k) consulting manufacturing of medical equipment ultrasound device regulatory support ultrasound research ultrasound testing devices ultrasound safety standards

Location

1898 Lefthand Cir, Longmont, Colorado, United States, 80501

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