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    StealthNet AI
    FDA Cybersecurity

    FDA Pentest for 510(k) Submissions. Submission-Ready in 48 Hours.

    StealthNet delivers an FDA pentest for connected devices, companion apps, and backend APIs, with reports mapped to FDA premarket guidance and AAMI TIR57 and delivered in as little as 48 hours. AI pentests start at $1,500 and hybrid (AI + human) pentests start at $5,000. For deeper background on scoping, read our medical device penetration testing guide, or see all penetration testing services.

    First report in 48h · From $1,500 · Free remediation retest

    FDA submissions without penetration test evidence face Refuse to Accept decisions. Most engagements can start within 24 hours.

    48-Hour Reports FDA Guidance Mapped US-Based Senior Testers AI + Human Hybrid
    Free tool: check FDA pentest readiness

    Get Scoped in 24 Hours

    Sample report

    Share a few details and pick a time to chat right after.

    FDA Guidance MappedAAMI TIR57 AlignedSubmission-Ready Reports

    No commitment. We'll follow up within 1 business day.

    Rather skip the form?

    Book a 30-minute scoping call instead

    Trusted by Companies Where Security Isn't Optional

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    Derma Monitor logo
    Avara Software logo
    High Point Networks logo

    What customers say

    Verified · Capterra

    Highly recommend StealthNet AI

    "StealthNet AI performed a thorough and comprehensive pen test, fast turnaround on conducting the test, they were very responsive, and it was great value."
    RB

    Richard B.

    Founder · Avara Software · Health, Wellness & Fitness

    Verified · Capterra

    The best choice for penetration testing

    "The testing was thorough and the reports were structured precisely for the regulatory requirements. Explanation of issues along with steps to reproduce and remediation advice were detailed and clear, making corrections a breeze."
    JM

    Jeremy M.

    Director · IKO Corp · Medical Devices

    How an FDA Cybersecurity Pentest Runs

    From device scope to 524B-ready evidence in days

    Scope the device, cloud, and mobile companion, AI agents map the attack surface, a senior tester confirms exploitability, and you receive an FDA premarket-ready package.

    From kickoff to auditor-ready report, delivered in 48 hours.

    The Problem

    Connected Devices Are Under Attack.

    FDA rejects your submission

    The FDA's 2023 premarket guidance now requires cybersecurity testing evidence. Submissions without penetration test results face Refuse to Accept (RTA) decisions.

    Patient safety is at stake

    Vulnerabilities in medical devices can directly impact patient health. Proactive testing prevents potentially life-threatening security incidents.

    Specialized testing is expensive

    Medical device security firms charge $30K to $80K for comprehensive testing. StealthNet delivers AI pentests starting at $1,500 and hybrid pentests from $5,000.

    The Solution

    Pentest Reports Built for FDA Submissions, Not Retrofitted for Them.

    Cost
    Traditional
    —$30K to $80K
    StealthNet
    AI: $1,500 / Hybrid: from $5,000
    Delivery
    Traditional
    —4 to 8 weeks
    StealthNet
    48 hours
    FDA Guidance Mapping
    Traditional
    —Manual / extra cost
    StealthNet
    Included
    Retest
    Traditional
    —Extra charge
    StealthNet
    Free
    Device Expertise
    Traditional
    —Varies
    StealthNet
    Specialized

    AI Pentest

    $1,500

    • 48-hour delivery
    • Exploit-validated findings
    • Mapped to FDA premarket guidance

    Best for: Post-market monitoring, companion app testing, API security

    Most Popular

    Hybrid (AI + Human) Pentest

    Starting at $5,000

    Typical engagements range from $5,000 to $15,000 depending on device complexity

    • AI attack simulation + senior US-based pentester validation
    • 48-hour first report
    • Dedicated project manager + private Slack channel
    • Submission-ready report + free retest included

    Best for: Pre-market submissions, 510(k) renewals, comprehensive device security

    Deliverables

    Mapped to FDA Cybersecurity Guidance.

    Device Security

    Testing of device firmware, communication protocols, and physical interfaces

    Backend & Cloud

    Assessment of cloud APIs, data storage, and device-to-server communications

    SBOM Validation

    Software composition analysis and known vulnerability identification

    Data Integrity

    Testing of patient data protection, encryption, and access controls

    Why StealthNet

    AI Handles Speed. Humans Validate Everything.

    A named, US-based senior tester validates every finding before your report is delivered.

    Reports are mapped to FDA premarket guidance and AAMI TIR57, ready for your submission package.

    Most clients receive their first report within 48 hours of scoping call completion.

    Medical device companies and SaMD teams have used StealthNet to support 510(k) submissions.

    FAQ

    FDA Pentesting Questions

    Yes. The FDA's premarket cybersecurity guidance (2023) requires manufacturers to provide evidence of cybersecurity testing, including penetration testing, as part of their 510(k), PMA, or De Novo submissions. Post-market, the FDA expects ongoing vulnerability monitoring and periodic security assessments.

    FDA medical device penetration testing evaluates the cybersecurity of connected medical devices, their companion applications, backend APIs, and cloud infrastructure. It identifies vulnerabilities that could compromise patient safety, data integrity, or device availability. This is exactly what the FDA's premarket guidance requires.

    Any device with network connectivity, wireless capabilities, or software components should undergo penetration testing. This includes infusion pumps, pacemakers, imaging systems, patient monitors, wearable devices, and their associated mobile apps and cloud services.

    Our reports map findings to the FDA's recognized consensus standards (AAMI TIR57, IEC 62443) and include threat modeling, vulnerability assessment, exploitation evidence, and remediation validation, all formatted for inclusion in your premarket submission package.

    Yes. The FDA requires manufacturers to maintain a cybersecurity vulnerability management program throughout the device lifecycle. Regular penetration testing demonstrates due diligence and helps identify emerging threats before they impact patient safety.
    Related Frameworks

    Other Compliance Pentests We Cover

    HIPAA Penetration Testing

    Healthcare apps + ePHI systems

    SOC 2 Penetration Testing

    Type I & Type II audit-ready

    PCI DSS Penetration Testing

    Cardholder data environments

    ISO 27001 Penetration Testing

    ISMS-aligned testing

    NIST 800-53 Penetration Testing

    Federal control mapping

    CMMC Penetration Testing

    DoD contractor compliance

    FedRAMP Penetration Testing

    Government cloud auth

    All Compliance Frameworks

    Pick your framework

    Before You Submit

    Quick FDA Pentest Questions

    Yes. The FDA's premarket cybersecurity guidance (2023) requires manufacturers to provide evidence of cybersecurity testing, including penetration testing, as part of their 510(k), PMA, or De Novo submissions. Post-market, the FDA expects ongoing vulnerability monitoring and periodic security assessments.

    FDA medical device penetration testing evaluates the cybersecurity of connected medical devices, their companion applications, backend APIs, and cloud infrastructure. It identifies vulnerabilities that could compromise patient safety, data integrity, or device availability. This is exactly what the FDA's premarket guidance requires.

    Any device with network connectivity, wireless capabilities, or software components should undergo penetration testing. This includes infusion pumps, pacemakers, imaging systems, patient monitors, wearable devices, and their associated mobile apps and cloud services.
    Related Services

    Pentest Services Used in FDA 510(k) Engagements

    Every compliance pentest pulls from these test-type services as needed. Scope is sized to your environment, not padded with hours.

    Hardware / IoT Pentest→

    Embedded device, firmware, and IoT testing

    Web App Pentest→

    OWASP Top 10 + business logic for browser apps

    API Pentest→

    REST, GraphQL, gRPC, and OpenAPI-driven testing

    Source Code Review→

    Secure code review and SAST for high-assurance apps

    Get Scoped

    Get Your FDA Pentest Scoped in 24 Hours

    Share a few details and we'll follow up within one business day.

    FDA Guidance MappedAAMI TIR57 AlignedSubmission-Ready Reports

    No commitment. We'll follow up within 1 business day.

    Rather skip the form?

    Book a 30-minute scoping call instead