Tell us a little about yourself and what is your role at Acertara? I manage our ISO/IEC 17025-2017 accredited ultrasound test lab and serve as a consultant for various companies who need ultrasound expertise. What would people never guess you do in your role? International committee meetings all seem to pick 6 AM Mountain Time … Continue reading
Wayne Moore 6/14/2022 More often than not when someone in the medical device space mentions the FDA the common response is a big frown. In terms of popularity, they are too often viewed as the IRS of medical devices – infinite power and no accountability. In my 40+ years in the medical device space I … Continue reading
Tell us a little about yourself and what is your role at Acertara? I was actually born in Boulder CO, but my family moved to Florida when I was little. I grew up in central Florida, the theme park capital of the world; I moved back to Colorado to go to the University of Colorado. … Continue reading
Wayne Moore 5/10/2022 Remanufacturing can have multiple definitions depending on what type of devices one is talking about and what industry you are in. For example, remanufacturing an HVAC means something entirely different than remanufacturing a medical device. In the world of medical devices, the United States Food and Drug Administration (FDA) decides what the … Continue reading
Tell us a little about yourself and what is your role at Acertara? My name is Wyatt, I am a Blue Heeler (Australian Cattle Dog), and I am 11 years old. I am getting grumpier the older I get. I do not like other dogs, to cuddle, or my arch nemesis- the vacuum. I do … Continue reading
Wayne Moore 4/12/2022 I attended the recent 47th Annual Regional Anesthesiology and Acute Pain Medicine Meeting in Las Vegas. I had no booth duty obligations, so I took the opportunity to sit in on multiple clinical presentations. The presentations on managing patients experiencing acute pain were very eye-opening for me, as they dealt with the … Continue reading
Tell us a little about yourself and what is your role at Acertara? My name is Kevin; I am an Air Force Veteran with a Bachelor’s Degree in Information Technology. I currently work in the Engineering wing as a Full Stack Software Developer, mainly working on our web-based applications and AWS Cloud configurations and optimization. … Continue reading
Wayne Moore 3/8/2022 At Acertara we are sometimes asked; “why do you charge more for the same probe repair than Company X?” In this cost-containment focused environment I consider that a fair question. Acertara operates its probe repair business under an ISO13485:2016 certified quality management system. Further, Acertara voluntarily complies with the strict FDA requirements … Continue reading
Tell us a little about yourself and what is your role at Acertara? I’ve lived in Colorado almost my whole life. On the weekends I’m usually hanging out with my dogs and partner, hiking, or riding my motorcycle. I’m an inspection tech so I get to test probes when they arrive. What do you like … Continue reading
Wayne Moore 2/8/2022 Through a recent uninformed decision, the United States Copyright office has given the green light for hackers to circumvent software locks on medical devices in order to allow access to the systems internal software architecture. This errant decision was based, in part, upon an FDA letter stating that allowing hackers to do this … Continue reading
