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++
Ensure++
Coverity
Codesonar
Codesurfer
OSEL is also using a dynamic analysis tool which has some static analysis capabilities called LDRA.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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