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
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
The Changing Competitive Landscape G. Wayne Moore, B.Sc., MBA, FASE 10/09/18 Why does one gigantic OEM company buy another gigantic OEM company, why do hospitals buy other hospitals, why do hospital systems buy other hospital systems, why does one huge healthcare technology management company buy another huge healthcare technology management company, why do private equity … Continue reading
Lessons Learned G. Wayne Moore, B.Sc., MBA, FASE 9/11/18 Twenty years ago, the company I founded, Sonora Medical Systems, was focused on creating both the technology and processes necessary to perform high-quality repairs on contemporary electronic array ultrasound probes. This effort led to the development and later the commercialization of the ultrasound probe tester known … Continue reading
“I’m just a blond monkey to you, aren’t I?” – Penny, Big Bang Theory G. Wayne Moore, B.Sc., MBA, FASE 8/14/18 In February of 1982, Intel introduced the 6MHz 80286 microprocessor. It used a 16-bit data bus, 134,000 transistors (1.5 microns), and offered protected mode operation. Initial price was US $360 each, in quantities of … Continue reading
I Love America G. Wayne Moore, B.Sc., MBA, FASE 7/02/18 I hope all reading this will have a blessed 4th of July and celebrate with me what it means to be a free America. I use the word “free” advisedly as freedom was indeed very costly for those who came before us. To that end, … Continue reading
Acertara has expanded our world-class probe repair offerings to include the Siemens Z6Ms transducers. Capabilities include repairs to address electrical leakage failures and restoring tip articulation functionality. Call the main office at 303-834-8413 or email us at [email protected] to get a quote or set up your repair! &nbs… Continue reading
The FDA 3rd Party Service Report G. Wayne Moore, B.Sc., MBA, FASE 6/12/18 Co·her·ence, noun – the quality of being logical and consistent. For those anticipating the above in the report released by the FDA my sincere condolences. For those believing that the report was affirmation on their particular point of view on the subject … Continue reading
The FDA 3rd Party Service Report – With Apologies to Firesign Theater G. Wayne Moore, B.Sc., MBA, FASE 5/8/18 If you have never heard of the comedy troop known as Firesign Theater you owe it to yourself to go to YouTube and listen to this album – often described as the funniest comedy album ever created. … Continue reading
3rd Party Repair and the FDA Report G. Wayne Moore, B.Sc., MBA, FASE 4/10/18 After my participation as invited faculty at AIUM’s annual scientific sessions in NYC, I jumped in a cab to catch a flight from Newark to Washington DC for the MITA Board of Directors meeting where Dr. Scott Gottlieb, the FDA Commissioner, was … Continue reading
