FDA Infusion Pump Software Safety Research

The FDA’s Software Engineering Laboratory has performed or been involved in a number of activities related to infusion pump safety, model based development and static analysis. The link provided is to FDA’s primarary web page on these activities.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.


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