G. Wayne Moore, B.Sc., MBA, FASE December 13, 2016 Radiological Society of North America (RSNA): My first RSNA was in 1986 (see photo to the right). MRI was still in its infancy, and ultrasound technology was just becoming digital; producing images that were almost recognizable. All imaging technologies were enhanced by significant advances in image … Continue reading
G. Wayne Moore 11/8/16 0.005%: Data mining in a flawed tunnel and then announcing a conclusion based on flawed data is not a compelling way to make a point. During the recent FDA Docket workshop on 3rd Party Repair the attendees, of which I was one, were treated to an amazingly dubious finding based on … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE October 11, 2016 Rumors are unverified information statements that people circulate to make sense of an unclear situation or to deal with a possible threat. Rumors are about issues or situations of topical interest. Rumors are like news except that news is accompanied by solid evidence; rumor is not. … Continue reading
G. Wayne Moore 9/13/16 September 11th, 2001. 15 years ago but as fresh in my memory today as it was then. I’m sure we all remember where we were that day. The week prior to 9/11, I had flown to Austria to visit a probe test equipment customer of ours; Kretz Ultrasound (purchased by GE … Continue reading
G. Wayne Moore August 10, 2016 Last month I wrote concerning the need and requirement (ISO as well as FDA – QSR) for using calibrated test equipment as part of a comprehensive quality management system for ultrasonic imaging medical devices. This includes testing both in the manufacturing environment as well as in servicing finished medical … Continue reading
G. Wayne Moore The United States Food and Drug Administration announced on March 4th 2016; “…the establishment of a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service and repair medical devices (known as “third-party entity or entities”). One may rightfully ask what … Continue reading
