The pdf at the link provided is a reprint of 2 articles entitled “Sensible Software Testing” parts 1 and 2, with the permission of the author Sean Beatty of High Impact Services. Mr. Beatty was a member of the working group that developed AAMI TIR32: Medical Device Software Risk Management. He is very experienced in...Read More
This topic contains selected references for electronic records and signatures compliance. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if...Read More
FDA and 62304 Training – Boston – June 4-6, 2019
3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well. John F. Murray, Jr., will be among the faculty!