G. Wayne Moore06/07/2021 Ultrasound probes are susceptible to both counterfeiting as well as unregulated remanufacturing1. Our friend, Merriam-Webster, defines counterfeit as “something made in imitation of something else with the intent to deceive.” How else would you describe removing and replacing critical performance OEM components with non-OEM components that have not undergone verification and validation … Continue reading
LONGMONT, CO August 14, 2019. Acertara Acoustic Laboratories, an ISO/IEC 17025:2017 accredited testing laboratory and ISO 13485:2016 certified ultrasound probe repair company, jumped up over 900 spots on Inc Magazine’s 39th annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies. “Everyone at Acertara is committed to working with our health … Continue reading
LONGMONT, CO April 27, 2020. Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2016 certified probe repair and new product development facility announces that Daniel Kreppein has joined Acertara as Executive Director of Commercial Development. Kreppein comes aboard along with several engineers as part of a … Continue reading
LONGMONT, CO August 14, 2019. Acertara Acoustic Laboratories, an ISO17025:2017 accredited testing laboratory and ISO13485:2016 certified ultrasound probe repair company, has been included in the prestigious Inc. 5000 list of the fastest-growing privately held companies in the United States. Growth at Acertara is notable in that it has been achieved completely organically and without the … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 12/11 /18 I just want to take this month’s newsletter to say how very much I appreciate our HTM customers. HTMs have an increasingly tough job taking care of more and more medical devices with an ever increasingly level of complexity, and with fewer and fewer resources to accomplish … Continue reading
Acertara had the pleasure of participating and attending the CEAI Conference in Illinois this past August. Check out the highlight video below! You might see some familiar faces! … Continue reading
Sunday, November 11th, 2018 Originally called Armistice Day, commemorating the signing of the agreement that ended World War I at 11:00 A.M., November 11, 1918, this federal holiday was changed to Veterans Day in 1954. At that time, it became a day to honor all the men and women who have served in the armed … Continue reading
The Next Chapter in the FDA 3rd Party Service Docket G. Wayne Moore, B.Sc., MBA, FASE 11/13 /18 At first glance at the title of the upcoming FDA workshop on this topic one may be excused in thinking; “Wait a minute, I thought the FDA has already defined what remanufacturing is!” FDA definition of remanufacturer: … Continue reading
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 … Continue reading
Acertara is delighted to announce the success in upgrading our Quality Management System from ISO 13485:2003 to ISO 13485:2016. Check out the link to see the Certificate and scope of work! ISO 13485: 2016 Certificate We are honored to be your one-stop shop for Probe Repair and Ultrasound Testing Equipment! Our Customer Service team is … Continue reading