FDA CDRH OSEL Software Analysis Tools

Brian Fitzgerald Deputy Division Director, Division of Electrical and Software Engineering, FDA CDRH, Office of Science & Engineering Laboratories, provided a list of software analysis tools FDA’s laboratory uses in evaluating medical device code. This was in response to a question posed at a recent AAMI Webinar that John Murray of FDA and Alan Kusinitz of SoftwareCPR presented.

FDA OSEL is using the following static analysis tools to a greater or lesser extent depending on the specific situation;
Polyspace C and C++
OSEL is also using a dynamic analysis tool which has some static analysis capabilities called LDRA.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.