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
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
Leave a message and we will contact you to schedule: