Medical device penetration testing requirements explained for FDA 510(k), De Novo, and PMA submissions.
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
275+ devices supported · No cybersecurity-related rejections to date
A plain-English breakdown of what the FDA, ANSI/AAMI SW96:2023 (with TIR57 as informative guidance), and eSTAR actually require for medical device penetration testing - the scope reviewers expect, the methodology they want documented, and the report format that survives a cybersecurity review without a deficiency letter.
Free 30-min call · Senior US expert · Mutual NDA before the call
Last updated
“Blue Goat provided testing on our system for cybersecurity and provided the necessary documentation to add to our regulatory submission.”
Bernie Lane, Engineer Manager, CSA Medical Inc
The FDA Test Report requirement asks for an explicit independence statement. Reviewers check for it before they read findings. Every Blue Goat Cyber report includes it, named oversight included.
Our pen test team has no role in writing your device firmware, cloud code, or mobile app, and never has. No remediation work, no architecture authorship, no source contributions. The independence statement in your report names the team and the boundary.
Inside Blue Goat Cyber, the pen test team is structurally separate from any consulting or remediation work we do for you. Oversight sits with our CTO and our VP of Regulatory Affairs, both named in the report so reviewers can trace accountability.
3 to 4 retest rounds is typical. Some submissions take 20+. One fixed fee covers them all. We do not bill per retest, per finding, or per round.
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
The pen test must demonstrate the device is 'cyber secure' - meaning every attack surface in the threat model has been exercised by an independent tester, not just a vendor self-attestation.
Reviewers expect a one-to-one mapping: every STRIDE threat → at least one test case → a documented result. A pen test that ignores threats in your own model is a near-automatic deficiency.
Device firmware, cloud backend + APIs, mobile companion apps, BLE/Wi-Fi/RF, and OTA update channels. Web-app-only testing on a connected medical device will be rejected.
Reviewers want to see the methodology (e.g. OWASP, PTES, NIST 800-115), tools used, test cases run, and the rationale for what was in/out of scope - not just a list of findings.
Executive summary, scope, methodology, findings with CVSS, remediation, retest results, and tester credentials - formatted to be dropped straight into the eSTAR cybersecurity attachments.
FDA expects testing performed by qualified personnel independent of the development team. Self-tests by the dev team rarely satisfy reviewers and frequently trigger deficiency letters.
These are the report-level gaps that trigger FDA cybersecurity deficiency letters even when the underlying testing was solid.
Report doesn't document that testers are independent of the development team. Reviewer flags it as a 524B(b)(2) gap regardless of test quality.
Threat model lists 30 STRIDE entries, pen test report exercises 8. Reviewer asks for the missing 22 - and the submission stalls.
Only the device firmware was tested. Cloud APIs, mobile companion apps, and OTA channels are out of scope. Reviewer requires the full attack surface.
Findings are listed but the report doesn't say which methodology (OWASP, PTES, NIST 800-115) was followed, what tools were used, or what was deliberately out of scope.
A finding list with severities but no CVSS vectors, no remediation guidance, and no retest evidence. Reviewer cannot evaluate residual risk.
If the report doesn't explicitly call out BLE, Wi-Fi, or RF testing, reviewers assume it wasn't done. Easy fix - say so in the report.
What you actually get versus a generic pen test shop or doing it in-house against a regulatory clock.
| Capability | Blue Goat Cyber | Generic pen test shop | In-house |
|---|---|---|---|
| Senior medical device cybersecurity engineers | Every project, US-based | Junior pen testers, rotating | Hard to hire and retain |
| FDA reviewer-format reports | eSTAR-attachable, 524B-mapped | Raw findings dump | Built from scratch each time |
| Retests included until uncontrolled risks are closed | Included, fixed fee | Billed per retest | Internal cycle cost |
| FDA submission track record | 275+ | Rare medical device experience | First submission risk |
| Mutual NDA before first call | Standard | Usually after SOW | n/a |
We sign a mutual NDA, then map your existing pen test (or planned one) against Section 524B, the FDA's Feb 3, 2026 premarket guidance, and ANSI/AAMI SW96:2023.
We walk your current pen test scope on the discovery call and return a fixed-fee quote within one business day showing exactly what's missing and what it takes to close.
If a re-scoped or supplemental pen test is the right move, we run it - device, cloud, mobile, wireless - and deliver a reviewer-format report eSTAR-attachable.
"Blue Goat provided testing on our system for cybersecurity and provided the necessary documentation to add to our regulatory submission. They were very knowledgeable in the requirements, and performed the testing onsite which made the logistics of equipment availability easier for us. The communication was excellent, and they were able to expedite the testing and provide final reports in a very short period of time."
If the FDA raises a cybersecurity deficiency, we fix it at no additional cost. 275+ devices supported.
We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.
No sales pressure. After the call, you get a concrete written strategy mapped to Section 524B and the FDA February 2026 final guidance.
Senior-led delivery on every FDA-facing artifact. No offshoring, no hourly billing. Revisions included. Every artifact is eSTAR-ready.
Who you're talking to
MBA, CISSP · U.S. Air Force Academy graduate · 30+ years in cybersecurity
Christian leads the senior medical device cybersecurity team behind 275+ devices supported. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30-minute call with a senior medical device cybersecurity expert. Fixed-fee quote within 24 hours of the call. Reviewer-ready report, retests included.
