Senior medical device cybersecurity engineers
- Blue Goat
- Every project, US-based
- Generic pen test shop
- Junior pen testers, rotating
- In-house
- Hard to hire and retain
Medical Device Pen Test Requirements
Pen Testing Requirements, Explained
Review penetration-testing evidence described by the FDA February 3, 2026 guidance: scope, methods, tester independence, Test Plan, Test Cases, and Test Report. Guidance recommendations and standards are distinct from Section 524B statutory duties.
Medical device penetration testing requirements explained for FDA 510(k), De Novo, and PMA submissions.
From about $15,000Simple device, excluding travel. Fixed fee after scoping.
Request a written scope instead- Fixed fee after scoping
- Uncontrolled-risk retests included
- Deficiency responses covered
275+ FDA submissions supported, zero cybersecurity rejections.
Last updated
FDA guidance: Cybersecurity Testing, Section C
Cybersecurity testing beyond standard software V&V
The FDA recommends cybersecurity testing in a security context, beyond standard software verification and validation. Security testing documentation and associated reports or assessments should be included in the premarket submission. Penetration testing is one part of this evidence, not a substitute for every testing activity.
The manufacturer retains design verification and validation procedures under ISO 13485 Subclauses 7.3.6 and 7.3.7, design input and output review, fixes, risk acceptance, and release decisions. Blue Goat provides scoped cybersecurity testing and evidence, not general software V&V or software validation services.
Security requirements and boundaries
The FDA recommends evidence that each security design input was implemented successfully, plus boundary analysis and the rationale for boundary assumptions. Our agreed test cases connect applicable security requirements, threats, expected secure behavior, and actual results. Exclusions and untested requirements remain visible.
Threat-mitigation effectiveness
Testing evidence should address risk controls represented in the Global System, Multi-Patient Harm, Updatability and Patchability, and Security Use Case security architecture views. The threat model and Threat Table are separate deliverables, linked to controls and test evidence. Review security-policy enforcement and, as appropriate, maximum-traffic performance, stability, and reliability. The proposal identifies included checks and other manufacturer evidence needed.
Vulnerability testing and analysis
Section C references ANSI/ISA 62443-4-1 and recommends considering the following testing and analysis evidence:
- Abuse or misuse cases, malformed and unexpected inputs, robustness, and fuzz testing.
- Attack surface analysis and vulnerability chaining.
- Closed-box known-vulnerability scanning.
- Software composition analysis of binary executable files.
- Static and dynamic code analysis, including hardcoded, default, easily guessed, or easily compromised credentials.
This is a guidance evidence checklist, not a promise that every method is included in standalone penetration testing. SAST, binary software composition analysis, SBOM work, and threat-model creation or rework are separate unless explicitly bundled. Other methods depend on agreed access, interfaces, risks, and scope. Automated scan output alone is not a penetration test.
Penetration-test evidence
Adversarial tests focus on discovering and exploiting product vulnerabilities to identify and characterize security-related issues. The FDA recommends providing penetration-test reports that include:
- Independence and technical expertise of testers.
- Scope of testing.
- Duration of testing.
- Testing methods employed.
- Test results, findings, and observations.
Our Test Plan, Test Cases, and Test Report connect scope, methods, requirements, threats, findings, clean results, limitations, and retests. Documented evidence does not establish regulatory acceptance or replace manufacturer review.
Source: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, February 3, 2026, Section C. Guidance recommendations are distinct from Section 524B statutory duties.
Included in your agreed scope
- Section 524B statutory duties distinguished from testing recommendations
- FDA Feb 3, 2026 final premarket guidance, pen test expectations
- ANSI/AAMI SW96:2023 (with TIR57 as informative), scope, methodology, and evidence requirements
- eSTAR cybersecurity attachments, what must be in the report
- Scope coverage: device, cloud, mobile, BLE/RF, OTA
- Testing evidence gaps and documented scope limitations
275+FDA submissions supported
0cybersecurity rejections
FDA Feb 2026 guidance · §V.C
Tester independence and oversight
Each Blue Goat report documents tester independence and named oversight, aligned to the FDA's February 2026 premarket cybersecurity guidance.
External independence
The testing report documents independence from device development. It identifies the testers, their technical expertise, and any relevant roles or relationships. Your engineers own device fixes.
Internal independence
The report records testing responsibilities and review oversight. Where Blue Goat also supplies consulting or documentation, the engagement identifies those roles and the testing-independence boundary.
One fixed fee
Retesting included until uncontrolled risks are closed
The agreed fixed fee includes unlimited retests until every finding with uncontrolled risk is closed. Your engineers implement fixes; the manufacturer owns risk disposition. We do not bill per retest.
- Every closed finding gets re-executed against the original exploit path
- Retest evidence is appended to the same report your reviewer sees
- Scope creep that introduces new surfaces is a separate quote, on purpose
Trusted by medical device teams worldwide
Lifecycle scope
What FDA reviewers expect in a medical device pen test
The proposal identifies included deliverables, exclusions, manufacturer inputs, and review responsibilities for this engagement.
01
Section 524B(b)(2) coverage
Section 524B(b)(2) establishes cybersecurity process and update duties, not a universal penetration-test script. The guidance describes testing evidence; scope follows device risks and architecture.
02
Scope tied to the threat model
Connect relevant threats, requirements, test identifiers, findings, and retests. Document exclusions and evidence gaps; a STRIDE classification alone is not a test or risk score.
03
All connected interfaces in scope
Review actual device, cloud, mobile, wireless, and update interfaces. The proposal identifies included device versions, interfaces, access, and exclusions.
04
Methodology documented
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.
05
Reviewer-format report + evidence
Executive summary, scope, methodology, findings with CVSS, remediation, retest results, and tester credentials, formatted to be dropped straight into the eSTAR cybersecurity attachments.
06
Independent tester
The FDA recommends reports documenting tester independence and technical expertise. State the testers' relationship to development and their qualifications without assuming an internal test is automatically unacceptable.
Illustrative security checks
Where pen test reports get cited as deficient
Review these potential documentation gaps against the actual test scope and evidence. They are not predictions of the FDA's review outcome.
No tester independence statement
Document tester independence and technical expertise as recommended in Section C. Section 524B does not itself prescribe a report template.
Scope doesn't match the threat model
Check whether test identifiers connect relevant threats and security requirements to actual results. Record omissions and rationale instead of inventing coverage counts.
Cloud or mobile out of scope
Compare tested interfaces with the system boundary and threat model. Document cloud, mobile, and update-channel coverage or exclusions and their rationale.
No methodology section
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.
Findings without CVSS or remediation
A finding list with severities but no CVSS vectors, no remediation guidance, and no retest evidence. Reviewer cannot evaluate residual risk.
BLE / RF assumed not tested
Identify the wireless interfaces actually tested, methods, results, and limitations. Do not claim testing solely by adding an interface name to the report.
What happens after you book the call
- 1Scoping
Review your device and evidence
Discuss architecture, available records, access, responsibilities, and target dates. Agree confidential handling before transferring device material.
- 2Proposal
Agree deliverables, fee, and dates
The proposal identifies included work, exclusions, manufacturer inputs, and delivery milestones. The 24-hour quote turnaround is separate from delivery, remediation, and review time.
- 3Agreed dates
Test, report, and retest
Deliver the Test Plan, Test Cases, and Test Report for the agreed device version and interfaces. Your engineers implement fixes; we retest findings with uncontrolled risk and update the evidence.
"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."
Blue Goat Cyber vs. the alternatives
What you actually get versus a generic pen test shop or doing it in-house against a regulatory clock.
FDA reviewer-format reports
- Blue Goat
- eSTAR-attachable, 524B-mapped
- Generic pen test shop
- Raw findings dump
- In-house
- Built from scratch each time
Retests included until uncontrolled risks are closed
- Blue Goat
- Included, fixed fee
- Generic pen test shop
- Billed per retest
- In-house
- Internal cycle cost
FDA submission track record
- Blue Goat
- 275+ FDA submissions supported, zero cybersecurity rejections.
- Generic pen test shop
- Rare medical device experience
- In-house
- First submission risk
Mutual NDA before first call
- Blue Goat
- Standard
- Generic pen test shop
- Usually after SOW
- In-house
- n/a
| 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+ FDA submissions supported, zero cybersecurity rejections. | Rare medical device experience | First submission risk |
| Mutual NDA before first call | Standard | Usually after SOW | n/a |
Support matched to your scope
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
Mutual NDA before the call
We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.
Fixed-fee quote within 24 hours of the call
The quote identifies deliverables, assumptions, and dates. Quote turnaround is separate from the time needed to deliver the work.
Senior US engineers, fixed fee
Senior-led cybersecurity work within the agreed scope. Your team reviews the evidence and owns risk, release, and submission decisions.
Common questions
Is a pen test required for every FDA submission?
The FDA's February 3, 2026 guidance recommends considering penetration testing among other cybersecurity testing activities. Section 524B establishes duties for applicable cyber devices, not a universal penetration-test script. Scope and evidence depend on the device, risks, architecture, and submission context.
Can our internal team run the pen test?
Reviewers expect independence. The guidance recommends qualified personnel with independence from development. Document qualifications and independence; Section 524B does not itself prescribe a vendor or guarantee acceptance.
What methodology does the FDA require?
Section C does not prescribe one penetration-testing methodology. It recommends documenting the methods employed. We document selected methods, tools, scope rationale, results, and limitations.
Do you sign an NDA before the requirements review?
Yes. Mutual NDA before the call so you can share architecture, prior pen test reports, and any FDA correspondence freely.
Are your testers US-based?
Yes. Senior US-based testers, independent of any party that wrote the device firmware or cloud code. Independence is documented in the report exactly as the FDA Test Report requirement specifies.
Who you're talking to
Christian Espinosa, Founder & CEO
MBA, CISSP · U.S. Air Force Academy graduate · 30+ years in cybersecurity
Christian leads the senior medical device cybersecurity team behind 275+ FDA submissions supported, zero cybersecurity rejections. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
Need to meet FDA pen test requirements?
30-minute call with a senior medical device cybersecurity expert. Fixed-fee quote within 24 hours of the call. Test Plan, Test Cases, Test Report, and scoped retests included.
Replies in 1 business dayMutual NDA firstUS-based senior engineerNo sales pitch