The final version of “ANSI/AAMI SW 87:2012 Application of quality management system concepts to medical device data systems” has been published. FDA initiated and participated in this work. Sherman Eagles, Sandy Hedberg, and Molly Ray of SoftwareCPR were on the working group and Alan Kusinitz of SoftwareCPR was a reviewer. SoftwareCPR can provide MDDS developers...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.