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
LONGMONT, CO September 12, 2016 Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2005 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2003 certified probe repair and new product development facility announces inventors G. Wayne Moore and James Gessert have been awarded United States patent # 9,375,201 for Remote Maintenance of Medical Imaging Devices. Commenting … 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
LONGMONT, CO July 21st, 2016 Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2005 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2003 certified probe repair and new product development facility announces the relocation of its headquarters to an expanded facility which coincides with the celebration of its five-year anniversary since opening for business. “This … Continue reading
Acertara Acoustic Laboratoriesis pleased to announce that Acertara’s Director of Quality and Regulatory Affairs, Ms. Callie Moore, BA,RAC,has successfully attained the credential of Regulatory Affairs Certified (RAC). The RAC is the only professional credential for medical regulatory professionals in the healthcare product sector and Ms.Moore is among a select group of 219 individuals worldwide to have earned the RAC credential in 2016. … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE July 12, 2016 Assuring the quality of a test device measurement used to assess the functionality of a medical imaging device is crucial. In order to achieve the finest objective measurement and then using that result in making the correct performance evaluation, calibration of test equipment as recommended by … 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