A straight answer on what FDA expects from your device.
Pick a time below. You'll talk to a security engineer, not a salesperson, and you'll leave with next steps either way.
- 1
Tell us where you are
Device type, submission path, timeline, and whether FDA has already asked you anything.
- 2
Hear where the gaps are
Which parts of your eSTAR cybersecurity evidence look thin, and which ones reviewers push on first.
- 3
Leave with a plan
What closing the gaps takes and in what order, whether or not we're the ones doing the work.
Who you talk to
Jose Bohorquez, PhD
President
Takes every first call. MIT-trained engineering PhD and cybersecurity expert.
Who runs the work
Mohamad Foustok
Chief Security Officer
Manages every engagement from kickoff to submission.
Dozens of submissions supported. Zero cybersecurity rejections by FDA. Ask about any of them.
- ISO 13485 Certified
- U.S.-Based Team
Send a note. We reply within one business day.
Three fields. Tell us the device, the submission path, and what's worrying you. The reply comes from the same engineers you'd meet on the call.