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.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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