The pdf at the link provided is a reprint of an article in the November 2010 issue of the Jounal of Medical Device Regulation entitled “US Medical Device Software Regulation”. This article was authored by Sherman Eagles, and Alan Kusinitz, Partners at SoftwareCPR. The article provides an overview of FDA regulations related software distributed in or as medical devices.
This is a reprint and posted with permission from the JMDR.
Overview of FDA Medical Device Software Regulation Article Reprint 1110