Today, Acertara announced the 20th anniversary of its ISO/IEC 17025:2017 accredited ultrasound acoustic testing laboratory. Working with ultrasound original equipment manufacturers (OEMs) and regulatory agencies around the world, the accredited ultrasound testing services provide OEMs with the quantitative IEC 60601-2-37 acoustic data required to obtain FDA 510(k) clearance to market their products in the United States and to receive CE labeling to sell their systems in the European Union.
Acertara’s acoustic laboratory is currently led by Nicholas Ellens, Ph.D., who came to Acertara from Johns Hopkins three years ago to expand the company’s metrology capabilities and to actively participate in International Technical Work Groups to develop new Standards for the ever-evolving transducer technologies.
“Acertara is the only independent ultrasound acoustic testing laboratory in the world that is accredited to ISO/IEC 17025:2017 and we are mindful of the essential role we play in bringing these incredible new ultrasound technologies to the health care community,” Levi Moore, Acertara’s president and COO said. “The experience we have developed in testing also plays a crucial role in our work related to designing, manufacturing, and repairing ultrasound transducers for a wide variety of customers including qualifying new repair materials to ensure safety and efficacy.”
Over the past 20 years Acertara has participated in more than 1,200 FDA 510(k), and CE submissions, working with both ultrasound devices and active implantable companies from more than 35 different countries.
For more information, visit www.acertaralabs.com.
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