The Lake Wobegon Effect 08/13/19 “The Lake Wobegon effect is a natural tendency to overestimate one’s capabilities and see oneself as better than others. Research psychologists refer to this tendency as self-enhancement bias and have found evidence for its existence in many domains.” Psychology Wiki Garrison Keillor (A Prairie Home Companion) made a hugely successful … Continue reading
Section 5.2.6.1.8 – Does this Change the 3rd Party Service Question? G. Wayne Moore, B.Sc., MBA, FASE 07/09 /19 The new ultrasound Guidance document, https://www.fda.gov/media/71100/download, addresses, at least in part, two key issues related to the 3rd Party service docket that began some three years ago; specifically who can do service and remanufacturing and … Continue reading
LONGMONT, CO June 18, 2019. Acertara Acoustic Laboratories, an ISO17025:2017 accredited testing laboratory and ISO13485:2016 certified ultrasound probe repair facility announces that its newest ultrasound probe testing device, ATLAS, has received the CE Mark allowing it to be sold within the European Union. ATLAS is a patent-pending, table-top sized, probe testing and analysis device that … Continue reading
Converging Medical Technologies G. Wayne Moore, B.Sc., MBA, FASE 06/11 /19 Ok, time to come clean; I am a Trekkie. There, I said it and I can get on with this month’s article – the convergence of rapidly evolving technology toward a real- life Tricorder; and it’s about time. In the 1986 movie Star Trek … Continue reading
Acertara is participating in the State of Colorado’s Innovative Industries Internship Program, providing internship opportunities for two software interns this year and we are thrilled to have Ben Gillett and Alice Lundberg join our team for the summer. Ben just completed his sophomore year at Colorado State University where he is earning a Bachelor of … Continue reading
LONGMONT, CO June 3, 2019. 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 it has received the latest version of accreditation from the ANSI National Accreditation Board for ISO/IEC 17025:2017 for ultrasound acoustic testing and calibration. … Continue reading
LONGMONT, CO May 14th, 2019. Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2005 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO 13485:2016 certified probe repair and new product development company is pleased to announce the completion of its Acertara-owned facility and relocation of its headquarters. “We are very excited to bring Acertara to … Continue reading
Rules, Regulations, Compliance, Substantial Equivalence, or What? G. Wayne Moore, B.Sc., MBA, FASE 05/14/19 As an ultrasound medical device regulatory expert, I receive a great many questions throughout the year regarding exactly what the FDA Guidance documents are. For example, are they requirements, rules, suggestions, or regulations? Below you will find the link to the … Continue reading
Guest Editorial Callie G. Moore, BA, RAC 4/9/2019 As our country begins the ramp-up to the 2020 elections a good deal of rhetoric and press has been aimed at what has generally been described as “healthcare reform”. Specifically, the mantra of “affordable” healthcare for all, without defining what affordable actually means. In the most general … Continue reading
Acertara has redefined its repair capabilities on Philips X5-1 xMatrix transducers. Repair capabilities include cosmetic repairs, lens replacements, CW mitigation, re-termination, and complex electrical repairs on both the explora and compact connectors. We have also expanded our inventory to include loaners for both models. Call the main office at 303-834-8413 or email us at Acertara_cares@Acertaralabs.com for your … Continue reading