Acertara Celebrates the 20th Anniversary of its Acoustic Testing Laboratory
Longmont, CO October 12, 2020. Acertara proudly announces the twentieth 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, our 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, PhD who came to Acertara from Johns Hopkins three years ago to expand our metrology capabilities and to actively participate in International Technical Work Groups to develop new Standards for the ever evolving transducer technologies. Commenting on this milestone Levi Moore, Acertara’s President and COO said; “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 healthcare community. 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 customer;, including qualifying new repair materials to ensure safety and efficacy.”
Over the last twenty 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.
About Acertara Acoustic Laboratories
Acertara Acoustic Laboratories, 1950 Lefthand Creek Lane, Longmont, Colorado 80501 is an ISO/IEC 17025:2017 accredited acoustic measurement laboratory and ISO13485:2016 ultrasound facility providing acoustic power testing services to ultrasound OEMs and regulatory bodies around the world, new product development, and advanced probe repair. Additional information about Acertara can be found on its Website at www.acertaralabs.com , by email at [email protected] or by phone at 303.834.8413.