Newsletter

0.005% and the FDA Service Docket

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

November 8, 2016 Acertara Labs Newsletter

Market Place Rumors – and the FDA Docket

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

October 13, 2016 Acertara Labs Newsletter

9/11 – One Man’s Journey

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

September 13, 2016 Acertara Labs Newsletter

A Paper Clip is Not a Probe Testing Device IEC 62736:2016

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

August 10, 2016 Acertara Labs Newsletter

Third Party Repairs of Medical Devices – Why All the Fuss?

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

March 8, 2016 Acertara Labs Newsletter