Regulatory Assistance & 510(k) Support

About Acertara Acoustic Laboratories

Acertara Acoustic Laboratories, founded in 1998, is a U.S.-based leader in ultrasound probe repair, acoustic power measurement, and regulatory consulting for medical device companies. It operates an ISO/IEC 17025:2017 accredited test lab and an ISO 13485:2016 certified quality management system, serving hospitals, imaging centers, and OEMs. The company leverages deep technical expertise to offer a full suite of services including contract engineering, low-volume manufacturing, and 510(k) submission support, positioning itself as a vital partner in the ultrasound value chain.